MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-09 for TITANIUM RETRACTOR ARM ASSY-9 INCHES 443A1070A manufactured by Integra Lifesciences Corporation Oh/usa.
[64665057]
When the surgeon was going to place one of the 443a1070a titanium retractor flexible arms to the halo ring, the support of the arm broke and got separated from the arm. He then tried to place the other two (2) arms and the same exactly thing happened. The patient was prepped for surgery and the incident led to a delay in surgery by 2 hours. There was no patient injury reported and the device was not yet in contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
[71024979]
Integra has completed their internal investigation on 02/15/2017. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: engineering was able to confirm the customer complaint on the retractor arms breaking device history record reviewed for this product id lot #139 manufactured on december 31, 2013 show no abnormalities related to the reported failure. The devices manufactured during this period passed all required inspection points with no associated mrr? S, variances or rework. A two year lookback in (b)(6) for this reported failure and or related to "broke and get separate from the arm" for this product id shows that no additional complaints were received. No new design or manufacturing trends have been identified. This issue will be monitored. Conclusion: in summary: engineering was able to verify the customer complaint. The root cause may be attributed to over tightening the knob during procedure. No other similar complaints were observed. Thus, this issue will be monitored for trending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2017-00010 |
| MDR Report Key | 6234335 |
| Date Received | 2017-01-09 |
| Date of Report | 2016-12-20 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2013-12-31 |
| Date Added to Maude | 2017-01-09 |
| 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 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 | TITANIUM RETRACTOR ARM ASSY-9 INCHES |
| Generic Name | RETRACTOR SYSTEM COMPONENTS |
| Product Code | GZT |
| Date Received | 2017-01-09 |
| Returned To Mfg | 2017-01-11 |
| Catalog Number | 443A1070A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-01-09 |