MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH QUICK COUPLING, SMALL; TAP,BONE

Catalog Number 311.43

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.(b)(6).The device was received and the product evaluation is in progress.No conclusion can be drawn.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) reports following: it was reported that after sterilization on (b)(6) 2018, it was found that the brown handles were staining with white peel on the packaging.No patient involvement reported.This report is for one (1) handle with quick coupling, small.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Device history review (dhr) review: part number: 311.43; synthes lot number: 6112415; supplier lot number: n/a; release to warehouse date: april 03, 2009; expiration date: n/a; manufactured by synthes (b)(4).No nonconformance records (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation summary: flow: visual (appearance not as expected).Visual inspection: the handle with quick coupling (part # 311.43, lot # 6112415, mfg # 03-apr-2009) was inspected at us customer quality (cq).Upon visual inspection, it was observed that the handle with quick coupling had discoloration throughout its handle.The handle with quick coupling shows signs of minimal wear and no other issues have been identified.The stained package mentioned in the event description was not returned to us cq.The received condition agrees with the complaint description.Document/specification review: the device drawings were reviewed.No design or manufacturing defect or deficiency was observed during the investigation.A device history review was performed for the returned instrument¿s lot number and no ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Investigation conclusion: the complaint condition is confirmed.While no definitive root cause could be determined, it is possible that the observed discoloration might have occurred due to the exposure of chemicals/liquids during the sterilization process.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HANDLE WITH QUICK COUPLING, SMALL
• Type of Device: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7633663
• MDR Text Key: 112184245
• Report Number: 2939274-2018-52599
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: (01)10886982187390
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.43
• Device Lot Number: 6112415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Date Manufacturer Received: 08/24/2018
• Patient Sequence Number: 1