MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-07 for INTEGRATOR MALLET 015-99603 manufactured by Integra York, Pa Inc..
[56931847]
Integra has completed their internal investigation on (b)(6) 2016. The investigation included: evaluation of actual device, review of device history records, review of complaints history. The returned integrator showing wears, repair markings and a broken center screw. The integrator was manually tested and the center screw is broken and does not function as designed. The complaint is confirmed; unsuccessful repair nonconforming product report / nonconforming material report history: none. Complaints metrics tracked, trended, and reviewed monthly with management. There was one intergrator mallet repaired (b)(6) 2016 returned used/processed showing wears, repair markings and a broken center screw. The complaint report has been confirmed as a repair issue; we have taken measures to address this issue.
Patient Sequence No: 1, Text Type: N, H10
[56931848]
It was reported that the integrator mallet is not cocking after being repaired for the same failure six days earlier. Product was in contact with the patient however, no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00165 |
| MDR Report Key | 6010883 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-07 |
| Date of Report | 2016-09-14 |
| Date Mfgr Received | 2016-09-14 |
| Date Added to Maude | 2016-10-07 |
| 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 | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRATOR MALLET |
| Generic Name | M54 - ORAL SURGERY |
| Product Code | LXM |
| Date Received | 2016-10-07 |
| Returned To Mfg | 2016-09-21 |
| Catalog Number | 015-99603 |
| Lot Number | 1606R (1789) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-07 |