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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is jnj representative.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, during routine incoming inspection of a loaner set at fsl (b)(6) site, it was observed that the handle with quick coupling, small was broken.There was no known patient or hospital involvement.This complaint involves one (1) device.This report is for (1) handle with quick coupling, small.This is report 1 of 1 (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part: 311.43; synthes lot: 9925607; manufacturing site: synthes jennersville.Release to warehouse date: november 11, 2015.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.Visual inspection: the handle with quick coupling, small was received at us customer quality (cq).Upon visual inspection, it was noticed that the handle component is cracked at the dowel pin assembly.No other defects were found on the device.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.Relevant actions have been taken to address the issue.Document/specification review: the following drawings were reviewed: tap handle for small taps and csk tap handle; handle, tap handle.The diameter and tolerance of bore hole in the handle was changed from rev.E to rev.F.Additionally, the diameter tolerance of the dowel pin hole in the handle was changed from rev.M to rev.N.These changes are relevant to the device condition.Relevant actions have been taken to identify the root cause of handle breakage and reduce its occurrence.Through 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 and the design updates were deemed effective.It was determined that the risk levels associated with a cracked complaint condition were low and medium and determined that an update to the risk documentation was required.Relevant actions have been taken to address the issue.Conclusion: the complaint was confirmed for the received device 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.Relevant actions have been taken to address the issue.No manufacturing issues were identified through the investigation.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.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: 10434914
• MDR Text Key: 204255412
• Report Number: 2939274-2020-03710
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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: 9925607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1