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

Catalog Number 311.43

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: there was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Device was used for treatment, not diagnosis.

Event Description

It was reported that on (b)(6) 2018, it was found out by the sterile processing department that a tap handle for screwdriver was cracked.There was no patient involvement.This complaint involves one (1) device.This report is1 of 1 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.Dhr review was completed.Part number: 311.43 , synthes lot number: 7067290 , supplier lot number: n/a , release to warehouse date: 13-nov-2012 , expiration date: n/a , manufactured by synthes jennersville.No 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.Customer quality conducted an investigation of the returned device.Flow: damaged: visual (appearance not as expected) visual inspection: the handle with quick coupling (part # 311.43, lot # 7067290, mfg # 13-nov-2012) was received at us cq with a crack measuring about 24.3 mm in length this agrees with the reported complaint condition, thus confirming the complaint.Dimensional inspection: a dimensional inspection was not performed as the root cause of the complaint condition has been identified as a device design deficiency, which has subsequently been addressed through appropriate steps.Document/specification review: the following drawing(s) was reviewed; tap handle for small taps and csk tap handle: 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.Approprate steps addressed the breakage of the blue radel handles through design change (effective 07-mar-2016).It was determined that the design tolerance of the device resulted in press fits between the handle bore and coupling shaft and the dowel pin hole and dowel pin.These tolerances were shown to be too tight for the press fit between the stainless-steel shafts and the ppsu holes in the handle.The interference fits generate internal stresses that can lead to the handles cracking, breaking during use, and breaking within the package.Therefore, tolerances too tight for press fit which is classified as a dimensional interaction was determined to be the root cause of the handles cracking and breaking.A corrective and/or preventative action is already launched.The worst-case risk level is medium due to a severity of sl2 and likelihood of occurrence of l2 based on adverse tissue reaction ¿ marginal.It was determined that product in the field and inventory is conforming and the relative risk and occurrence does not require field action including immediate correction.Conclusion: the complaint condition is confirmed as the handle with quick coupling (part # 311.43, lot # 7067290) was received cracked.During the investigation, no unidentified product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition and during investigation it was determined that appropriate steps have been already launched address the given complaint condition.No new malfunctions were observed during the course of this investigation.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 that on september 13, 2018, the sterile processing department noticed that the handle with quick coupling was cracked.There was no patient and procedure involvement.

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 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: 7936511
• MDR Text Key: 122805627
• Report Number: 2939274-2018-54177
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• 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: 7067290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1