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

No patient involvement reported.Date of event is unknown.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 2 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history review (dhr) review: a device history review was not able to be performed as the dhr was not available.The device is older than 15 years and according to inspection sheet - manufacturing documents for instruments had to be stored only for 10 years.Investigation summary: flow: visual (appearance not as expected).Visual inspection: the handle with quick coupling (part # 311.43, lot # 2134, mfg # unknown) 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were reviewed.With the device being older than 15 years, during cq investigation, current device drawings and other superseded drawings were not able to be accessed.No design or manufacturing defect or deficiency was observed during the investigation.A device history review was not able to be performed as the dhr was not available.The device is older than 15 years.According to inspection sheet (filing and archiving of specification documents), which was in place till august 2014 states that the manufacturing documents for instruments had to be stored for 10 years.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: 7633675
• MDR Text Key: 112573301
• Report Number: 2939274-2018-52598
• 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: 2134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Date Manufacturer Received: 08/27/2018
• Patient Sequence Number: 1