MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDE/FIXED HAMMER 400 GRAMS; AWL, GUIDE

Model Number	03.010.058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.No facility information available.Reporter is company representative.Without a lot number the device history records review could not be completed.Product was not returned.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 an unknown date, the handle of the slide/fixed hammer split and broke apart.It was noted that the device had been dropped in sterile processing department (spd).There was no patient involvement.  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.Part: 03.010.058; lot: 4803824; supplier lot: n/a; manufacture date or release to warehouse date: december 16, 2004; expiration date: n/a; supplier/manufacture site: envision manufacturing inc / brandywine review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Visual inspection: the slide/fixed hammer 400 grams was received with the phenolic handle broken off from the shaft.The handle was returned and was split in half vertically.No other issues were identified with the returned components of the device.The device failure/defect of broken handle was identified during the investigation and is related to the reported complaint condition.Dimensional inspection: drawing: hammer shaft feature: shaft diameter (for handle) result: conforming dimensional inspection of the handle could not be conducted due to post manufacturing damage.Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed.Hammer, 400 gram hammer handle hammer shaft during the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the slide/fixed hammer 400 grams as it was received with the phenolic handle broken off from the shaft.The handle was returned and was split in half vertically.While no definitive root cause could be determined, it is likely that the impact force from dropping the device caused the handle to break.It is possible that over 14 years of impact forces has contributed to the complaint condition also.During this investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.

• Brand Name: SLIDE/FIXED HAMMER 400 GRAMS
• Common Device Name: AWL, GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8777169
• Report Number: 2939274-2019-59100
• Device Sequence Number: 19327351
• Product Code: FZY
• UDI-Device Identifier: 10886982067296
• UDI-Public: (01)10886982067296
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 03.010.058
• Device Catalogue Number: 03.010.058
• Device Lot Number: 4803824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1