MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCK CRIMPER; MISC ORTHO SURGICAL INSTR

Model Number	388.474
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is company representative 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 evaluation at the loaner's department, the lock crimper was found broken.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) lock crimper.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.D4: supplier lot number: (b)(4).H3, h6: a product investigation was conducted.Visual inspection: the lock crimper (part # 388.474 / lot # 5260794) was received at us cq.The sliding piece of the locking crimper was received unattached from the device.There was no evidence of device breakage or fracture, rather the device came apart due to a missing screw.The overall complaint was not confirmed as there was no device breakage.Yes; pivot screw was missing from the assembly.Dimensional inspection: dimensional inspection was not performed as there was a definitive finding of a missing component.Conclusion: the overall complaint was not confirmed for the received lock crimper (part # 388.474 / lot # 5260794) as there was no evidence of device breakage.The assembly came undone due to a missing screw.Although no definitive root-cause can be determined, the screw may have come apart at some point during the device¿s lifecycle (13+ years).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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 388.474.Lot number: a7pa21 (wo# (b)(4).Manufacturing site: tuttlingen.Release to warehouse date: 23-may-2006.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Review of raw material certificate could not be established during this review due to the age of the device (over 13 years old).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.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: LOCK CRIMPER
• 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: 9327893
• Report Number: 2939274-2019-62215
• Device Sequence Number: 2498284
• Product Code: LXH
• UDI-Device Identifier: 10705034773148
• UDI-Public: (01)10705034773148
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 388.474
• Device Catalogue Number: 388.474
• Device Lot Number: 5260794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1