MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-12-10 for BOXED CHISEL 72.13.02-10 manufactured by Zimmer Gmbh.
[5220758]
The device has been investigated and the result has made available. The device manufacturing quality records indicate that the product met all requirements to perform as intended. During the trend analysis, a trend was identified. Criteria to fulfill a trend are 3 incidents in 1 month. The same error pattern has been recognized and zimmer (b)(4) is looking to investigate the issue. The investigation is temporarily set for september 15, 2014 to start an investigation and to create an action plan. Review of incoming information: it was reported that the device broke during surgery. No further detail was given.
Patient Sequence No: 1, Text Type: D, B5
[12614944]
During visual examination, it was seen the tip of the boxed chisel was clearly tht the sharp end of it was notched off. The surgical technique for cls brevius with kinectiv (lit. No. 06. 02196. 012; ed. 03/2011:p. 11) explained how to use the bosed chisel. "identity the mid femoral shaft extension intraoperative as view on the a/p and lateral radiographs. This is usually in the area of the piriformis tendon insertion in the junction between the medial trochanter and lateral femoral neck. Use the boxed chisel to remove the medial portion of the greater trochanter and lateral portion of the femoral neck. The orientation of the boxed chisel should follow the natural anteversion of the femur without the need to build-in additional anteversion as this can be achieved with kinectiv necks. The space in this area should not be larger than the rasp or implant but should be large enough for the passage of each sequential rasp to ensure neutral rasp/implant alignment. Insufficient space may result in improper stem positioning. It is important to lateralize the starting envelope for rasping and implant insertion. Assessment of the amount of trochanteric overlap over th proximal femoral canal on the preoperative a/p radiograph can be useful in determining the degree of lateralization necessary to ensure neutral component positioning. " as a summary, the reported issue could happen if the instrument is incorrectly used by the not following the surgical technique. Another possibility for the breakage of the chisel tip is when too much force/strong impaction/torque force during the surgery which is indicative of not familiar with the surgical technique. However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for the investigation is closed. Zimmer reference number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2014-04184 |
| MDR Report Key | 4344798 |
| Report Source | 01,05 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-11-30 |
| Date of Event | 2014-10-30 |
| Date Mfgr Received | 2014-11-10 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-12-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 57426763 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOXED CHISEL |
| Generic Name | BOXED CHISEL |
| Product Code | KDG |
| Date Received | 2014-12-10 |
| Returned To Mfg | 2014-12-02 |
| Catalog Number | 72.13.02-10 |
| Lot Number | 14.944229 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 WINTERTHUR SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-10 |