MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REAMING ROD PUSH ROD WITH BALL HANDLE; REAMER

Model Number	03.010.093
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.The device has been 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 or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that the reaming rod push with ball handle was bent.There was no patient involvement.This report is for 1 reaming rod push rod with ball handle.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part number: 03.010.093; lot number: a7oa28; manufacturing site: tuttlingen; release to warehouse date: week 28, 2005.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 15 years old).Visual inspection: the reaming rod push rod with ball handle (product code: 03.010.093, lot number: a7oa28) was received at us customer quality (cq) for investigation.Visual inspection of the received device indicated that the 3.0 mm rod component of the device was slightly bent.Thus, the complaint condition was confirmed for the received device.Device failure/defect identified? yes.Dimensional inspection: drawing shaft: 3 +0.05 mm/- 0.10 mm.-measured dimensions: near bent location: 2.97 mm; conforming device used: ca 215p.Document/specification review: the following documents were reviewed as part of this investigation: reaming rod push rod with ball handle.Reaming rod push rod.3.0mm rod.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed for the received device as a component in the device was bent.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: REAMING ROD PUSH ROD WITH BALL HANDLE
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10225656
• Report Number: 2939274-2020-03074
• Device Sequence Number: 11587839
• Product Code: HTO
• UDI-Device Identifier: 10886982067647
• UDI-Public: (01)10886982067647
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 03.010.093
• Device Catalogue Number: 03.010.093
• Device Lot Number: A7 OA 28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1