MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ACF TRIAL SPACER HANDLE; FORCEPS

Model Number	396.989
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 unknown procedure, the one (1) trial spacer handle rod portion that runs through the middle, broke.The case was delayed by two (2) minutes.The procedure was successfully completed.The patient outcome is unknown.Concomitant device reported: acf detachable trial spacer lordotic 6 mm: (part#: 396.922 lot#: unknown quantity: 1).This report is for one (1) acf trial spacer 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.H10 additional narrative: b5: updated event description provided for reporting.H3, h4, h6: a review of the device history record: device history lot.Part: 396.989.Lot: 1556568.Manufacturing site: haegendorf.Release to warehouse date: 18.Oct.2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Only top level of the device history record reviewed as sub-components are not lot tracked.H3, h6: investigation summary background/ updated event description: it was reported that on (b)(6) 2019, during an unknown procedure, the one (1) trial spacer handle rod portion that runs through the middle, broke.The case was delayed only by a couple of minutes.Procedure and patient outcome were unknown.This complaint involves one (1) device.Investigation flow: broken.Visual inspection: acf trial spacer handle were received at cq.Visual inspection the device revealed that the shaft that passes through the handle was broken at the rotating screw.Thus, the complaint is confirmed.The remaining portions of the device shows normal surface wear with consistent use for over 12 years.The received condition agree with the complaint description.Dimensional inspection: cannot be performed due to post manufacturing damage.Document/ specification review: the following drawings were reviewed during the investigation: implant holder 4.5 asm, shaft for implant holder.No design issues or discrepancies were noted during the investigation.Dhr review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Only top level of the device history record reviewed as sub-components are not lot tracked.Investigation conclusion: visual inspection of the returned device, dhr review of the part with given lot number, document/ specification review were performed at cq.A definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.The most likely cause is rough handling of the device.This complaint is 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.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
4/22/2019: update: concomitant part/lot was discovered during (ir) investigation report.Concomitant device: product code: 396.922 lot #: 6554757 qty: 1 was returned as a concomitant device without an alleged complaint condition.

• Brand Name: ACF TRIAL SPACER HANDLE
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8523687
• Report Number: 2939274-2019-57527
• Device Sequence Number: 2675789
• Product Code: HTD
• UDI-Device Identifier: 10705034778198
• UDI-Public: (01)10705034778198
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: 396.989
• Device Catalogue Number: 396.989
• Device Lot Number: 1556568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERVIOS TRIAL-IMPL WEDGE-SHAPED SIZ 6 DB