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

Model Number 311.43

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on an unknown date, one (1) handle with quick coupling was found to have a broken handle.The issue was discovered during routine inspection.There was no patient involvement.This report is for one (1) handle with quick coupling, small.This is report 1 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.H3, h6: a product investigation was conducted.Visual inspection: handle with quick coupling, small was received at us cq.Upon visual inspection at cq, it is observed that the handle was broken near the end of the shaft hole and has a vertical crack on the remaining handle piece on the device.The crack was across the location of the dowel pin.The broken handle piece was returned.No other issues were identified with the returned components of the device.The device failure/defect of a broken/cracked handle was identified during the investigation.Dimensional inspection: a dimensional inspection was not performed during this investigation as the root cause of the device condition has been identified as a device design deficiency, which has subsequently been addressed through corrective and preventative action (capa).Document/specification review: the relevant drawings were reviewed during the investigation: the diameter and tolerance of bore hole in the handle was changed in relevant drawing.Additionally, the diameter tolerance of the dowel pin hole in the handle was changed in the relevant drawing.These changes were made due to capa and are relevant to the device condition.Capa was launched on 03 nov 2015 to identify the root cause of handle breakage and reduce its occurrence.Through the capa investigation, it was determined that the root cause of the handle cracking was that the tolerances of the holes in the handle were too tight.Depending on the material condition, the press fit between the metallic shaft/dowel pin and their corresponding holes in the handle could lead to an excessive interference fit condition, in which internal stresses within the handle are created.These internal stresses could lead to the handle cracking and/or breaking.The respective drawings were updated through action activity and the design updates were deemed effective through effectiveness actions.Hhe determined the risk levels associated with a cracked complaint condition were low and medium and determined that an update to the risk documentation was required, which was done through capa.The capa investigation determined that a new, limited scope dcrm would be created through action activity to document the occurrence rates, severity levels and harms for device 311.43.The new dcrm was approved and released on 20 jan 2017.Investigation conclusion: the reported complaint condition of broken is confirmed for the handle with quick coupling, small as the instrument was received with a vertical crack on the handle.A valid design defect was identified as the root cause of the cracked condition.Capa was launched to address the design defect and was closed on 02 aug 2017 after effectiveness monitoring of the design changes was deemed effective.No manufacturing issues were identified through the investigation.A corrective and/or preventative action has already been launched and completed to address the design deficiency.See related action.Based on these findings, no additional corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part #: 311.43, synthes lot number: 7292888, manufacturing site: synthes jennersville , release to warehouse date: 29-mar-2013.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: 10503389
• MDR Text Key: 205964342
• Report Number: 2939274-2020-04019
• 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
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.43
• Device Catalogue Number: 311.43
• Device Lot Number: 7292888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1