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

Catalog Number 311.43

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 (b)(6) 2019, the handle with quick coupling was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves ten (10) devices.This is 5 of 10 for report (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: part # 311.43.Synthes lot # 7067912.Supplier lot # na.Release to warehouse date: 08 nov 2012.Manufactured by synthes jennersville.No ncr's were generated during production.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 device was received with a vertical crack on the handle.The crack was across the location of the dowel pin.The instrument/handle was not separated into two pieces.The dowel pin does not appear to have shifted in position.No other issues were identified with the returned components of the device.The received condition is consistent with the complaint condition thus the complaint is confirmed.Device failure/defect identified? yes; the device failure/defect of cracked handle is related to the reported complaint condition of broken.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 a capa.Document/specification review: the diameter and tolerance of bore hole in the handle was changed from ø4.4 mm +0/-0.05 mm in the drawing to ø4.5 mm +0.05/-0 mm.Additionally, the diameter tolerance of the dowel pin hole in the handle was changed from ø2 mm +0/-0.3 mm to ø2 mm +0/-0.02 mm.These changes were made due to the capa and are relevant to the device condition.The 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 and the design updates were deemed effective.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 the capa.The capa investigation determined that a new, limited scope dcrm would be created to document the occurrence rates, severity levels and harms for device 311.43.The new dcrm was approved and released on 20 jan 2017.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.A 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 upon 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: 9322809
• MDR Text Key: 197185083
• Report Number: 2939274-2019-62176
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• 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: 7067912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1