MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOHMANN RETRACTOR 8MM NARROW TIP 215MM

Model Number	399.197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a synthes 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 or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of a loaner set, the hohmann retractor was observed to be broken.There were no patient and surgical involvement.This complaint involves one (1) hohmann retractor 8mm narrow tip 215mm.This is 1 fo 1 for report (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.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: hohmann retractor 8mm narrow tip 215mm was received at us cq.Upon visual inspection at cq, it is observed that the distal tip of the retractor was slightly deformed but not broken.There were few discolored spots found on the surface of the body which would not contribute to the complaint condition.Thus, the reported broken condition cannot be confirmed.Dimensional inspection: dimensional inspection of the received device was performed at cq.The thickness of the retractor near the deformed location was measured and is within specification as per the drawing.Document/ specification review: the following drawings were reviewed during the investigation: retractor, hoffmann 8mm width, 210mm length, narrow tip no design issues or discrepancies were noted during the investigation.Investigation conclusion: visual inspection and dimensional inspection of the returned device, and document/ specification review were performed at cq.While a definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.This complaint is not being confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified during this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part number: 399.197; lot number: t152850; manufacturing site: tuttlingen; release to warehouse date: 09-jun-2017.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: HOHMANN RETRACTOR 8MM NARROW TIP 215MM
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9219717
• Report Number: 2939274-2019-61653
• Device Sequence Number: 2985818
• Product Code: GAD
• UDI-Device Identifier: 10886982202543
• UDI-Public: (01)10886982202543
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 399.197
• Device Catalogue Number: 399.197
• Device Lot Number: T152850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1