MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SILICONE HANDLE QUICK COUPLING/SHORT; MISC ORTHO SURGICAL INSTR

Model Number	03.111.013
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
It was reported that on (b)(6) 2019, during an orthopedic procedure, the shaft for trephine attachments and short silicone handle quick coupling were lodged together after appropriate use to obtain bone graft.The surgeon tried to dislodged the two instruments, however, they became lodged in one another and are no longer functional.There were no fragments generated.Procedure was completed successfully with no delay.There was no patient consequence.This report is for one (1) short silicone handle quick coupling.This is report 2 of 2 for (b)(4).
Additional 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, h4, h6: device history records review was completed for part: 03.111.013, lot: 2550622.Manufacturing location: bettlach, release to warehouse date: jan 07, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.H3, h6: product investigation was completed.The flanges on the shaft of silicone handle quick coupling/short inspected visually and found damages possibly due to use of pliers on the flanges on the shaft and also found that flanges were bent outwards which would be contributed to the complaint condition.Relevant drawings were reviewed during investigation and no design issues were noted.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.The material was reviewed, and the hardness value was confirmed to meet the specification with no non-conformance noted.Although a definitive root cause could not be determined, it is also possible that the rough handling of the device during use and/or processing could have contributed to the complaint condition.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no 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: SILICONE HANDLE QUICK COUPLING/SHORT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8367540
• Report Number: 2939274-2019-56658
• Device Sequence Number: 1924101
• Product Code: LXH
• UDI-Device Identifier: 10886982072122
• UDI-Public: (01)10886982072122
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.111.013
• Device Catalogue Number: 03.111.013
• Device Lot Number: 2550622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1