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

Catalog Number 311.43

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record.Device history lot dhr not available as device is older than 20 years.Last documented lot in erp system is lot 2175 manufactured in february 1998.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to se_075477 (filing and archiving of specification documents) version ai, which was in place till august 2014.Investigation summary background: it was reported on an unknown date, there was an unknown allegation of the handle with quick coupling.Item was found post op in sterile processing in a peel pack.It is unknown if there were procedure and patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the handle with quick coupling, small (p/n 311.43 lot 2144) was received with the handle completely broken off from the shaft assembly.The handle was broken off into three (3) pieces.Additionally, the dowel pin was deformed/bent.No other issues were identified with the returned components of the device.Dimensional inspection: dimensional inspection could not be conducted due to post manufacturing damage.Document/specification review: as the device is older than 20 years, the following drawings were reviewed.D0003870 rev.00 to se_201129 rev.D, d0003868 rev.00 to se_455892 rev.D.Dco_052516 changed the handle¿s material from phenolic/canevasit to radel r 5000 blue (ppsu).This change was made for the improved mechanical properties of ppsu.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the handle with quick coupling, small (p/n 311.43 lot 2144) as the handle was broken off into three (3) pieces.Additionally, the dowel pin was deformed/bent.While no definitive root cause could be determined, the condition of the instrument is consistent with handling, use, and reprocessing over its lifetime (20+ years).During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

Event Description

It was reported on an unknown date, there was an unknown allegation of the handle with quick coupling.Item was found post op in sterile processing in a peel pack.It is unknown if there were procedure and patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• 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
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8786890
• MDR Text Key: 152067131
• Report Number: 2939274-2019-59173
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: (01)10886982187390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• 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: 2144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1