MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-02 for SLOTTED MALLET N/A 281001003 manufactured by Zimmer Biomet, Inc..
[88234049]
The complaint was confirmed through decontamination images. This is a known issue with the root cause having been previously identified to be related to the product design. The failure mode has been previously addressed in a health hazard evaluation (hhe). Corrective action for this failure mode has already been taken. There is no indication of a manufacturing related defect and it is likely that the product was distributed in conformance to the specification in effect at the time. The product was made prior to the implementation of the corrective action based off lot numbering scheme. The trend of reported complaints appears to be upward based off yearly complaints. However, if you look at monthly complaints in 2013 and 2014, the trend appears to be downward with a minor spike in (b)(6) 2013 with last complaint seen in (b)(6) 2014. There are no circumstances related to this event that contradict the conclusion of the previously performed hhe which concluded that the risk is broadly acceptable. No further action is required at this time. No supplier dhr could be located, therefore a review of the device history records could not be performed. Review of complaint history was done. Corrective and preventive action taken in (b)(4). Relayed completion of the investigation to the sales rep via phone on august 25, 2014. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[88234050]
It was reported that during a smith and nephew total hip arthroplasty, the surgeon was using a slotted mallet when the handle fractured during impaction. Another mallet was used to complete the procedure with no delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07582 |
| MDR Report Key | 6907225 |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-28 |
| Date Mfgr Received | 2014-05-14 |
| Date Added to Maude | 2017-10-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SLOTTED MALLET |
| Generic Name | INSTRUMENT - JOINT |
| Product Code | HXL |
| Date Received | 2017-10-02 |
| Returned To Mfg | 2014-08-06 |
| Model Number | N/A |
| Catalog Number | 281001003 |
| Lot Number | EC2J64 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-02 |