MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-14 for 9 INCH RETRACTOR ARM ASSEMBLY 438A1011 manufactured by Integra Lifesciences Corporation Oh/usa.
[40542683]
It was reported that the mayfield retractor broke at the joint. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[45891997]
Integra has completed their internal investigation on 13apr2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaint history. Results: evaluation of device: 438a1011 9" (229mm) halo flex arm lot147. Halo flex arms are first time in service. Cable got damaged and needed to get exchanged. One ball joint was missing and had to be added. The device history record for the unit(s) listed in this complaint under lot code/work order: (b)(4) on 08/08/2014. A total of (b)(4) retractors were produced of this lot and a sample of (b)(4) was inspected per wi 103. No abnormalities relate to reported incident found nor where there any variances, mrr? S or reworks associated with this lot/work order number. A two year lookback for this reported failure and or related to " broke" for this product family shows that no additional complaints were received. No new design or manufacturing trends have been identified. Device was sent in without ball joint and damaged cables. The root cause could be wear and tear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2016-00047 |
| MDR Report Key | 5498055 |
| Date Received | 2016-03-14 |
| Date of Report | 2016-02-18 |
| Date Mfgr Received | 2016-04-13 |
| Device Manufacturer Date | 2014-08-08 |
| Date Added to Maude | 2016-03-14 |
| 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 | MRS. ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9 INCH RETRACTOR ARM ASSEMBLY |
| Generic Name | RETRACTOR SYSTEM COMPONENTS |
| Product Code | GZT |
| Date Received | 2016-03-14 |
| Returned To Mfg | 2016-02-22 |
| Catalog Number | 438A1011 |
| Lot Number | 147 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-14 |