MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STRAIGHT BALL SPIKE 337MM; RETRACTOR

Model Number	398.54
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, the reporter was given a straight ball spike with a flattened point during an inspection.There was no patient involvement.This report is for 1 straight ball spike 337mm.This is report 1 of 1 for complaint (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.Additional narrative: part 398.54, lot t113986: manufacturing site: tuttlingen.Release to warehouse date: april 14, 2015.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: upon visual inspection it was noticed that the tip of the device was blunt and not sharp as per the design.No other defects were identified on the device.No dimensional inspection was performed due to the post manufacturing damage.The relevant drawings were reviewed.The complaint condition of bent is confirmed for the returned device.The reported condition of stripped was not confirmed as there are no stripped defect identified on the tip of the device.The unintended external forces might have contributed to the reported complaint condition.There was no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.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: STRAIGHT BALL SPIKE 337MM
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10945580
• Report Number: 2939274-2020-05445
• Device Sequence Number: 3170567
• Product Code: GAD
• UDI-Device Identifier: 10886982201430
• UDI-Public: (01)10886982201430
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 398.54
• Device Catalogue Number: 398.54
• Device Lot Number: T113986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1