MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMER GUIDE FOR SLIDE HAMMER; HAMMER,SURGICAL

Model Number	357.22
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the hammer guide for slide hammer had broken threads.There was no patient consequence.There is no further information available.This report is for one (1) hammer guide for slide hammer.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: d9: h3, h4, h6: part: 357.220.Lot: 73533.Manufacturing site: bettlach.Part/lot combination are unknown at synthes gmbh, last tracked lot is at 2001.(lot with over 10000 numbered).Due to the age of more than 20 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure is for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.Visual inspection: the hammer guide for slide hammer (p/n: 357.22, lot number: 73533) was received at us customer quality (cq).Visual inspection of the complaint device showed the distal tip threads were stripped and damaged.No components appeared broken.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not 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 distal tip threads were stripped and damaged even though no components appeared broken.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: HAMMER GUIDE FOR SLIDE HAMMER
• 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: 11599245
• Report Number: 2939274-2021-01636
• Device Sequence Number: 3402714
• Product Code: FZY
• UDI-Device Identifier: 10886982195913
• UDI-Public: 10886982195913
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 357.22
• Device Catalogue Number: 357.22
• Device Lot Number: 73533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1