MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDE/FIXED HAMMER 700 GRAMS; HAMMER,SURGICAL

Model Number	03.010.056
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
Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 hammer fell apart in the washer.There was no patient involvement.This report is for one slide/fixed hammer 700 grams.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.H3, h6: part # 03.010.056, synthes lot # 4803820, supplier lot # na, release to warehouse date: 04 mar 2005, manufactured by synthes brandywine.An mrr was generated for no certificate of compliance and qty 2 not staked at thread.This non-conformance is not relevant to the complaint condition since the certificate of compliance was received and the qty 1 device was reworked by supplier to pass inspection.Review of the device history record(s) 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 700 grams (p/n: 03.010.056, lot number: 4803820) was received at us customer quality (cq).Visual inspection of the complaint device showed the handle of the hammer had broken apart into several pieces.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device handle is broken into several pieces.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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.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 700 GRAMS
• Common Device Name: HAMMER,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9617838
• Report Number: 2939274-2020-00333
• Device Sequence Number: 2739332
• Product Code: FZY
• UDI-Device Identifier: 10886982067289
• UDI-Public: (01)10886982067289
• Combination Product (Y/N): N
• 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): 01/01/2020

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: 03.010.056
• Device Catalogue Number: 03.010.056
• Device Lot Number: 4803820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/01/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/19/2020
• Patient Sequence Number: 1