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)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.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 (b)(6) 2020, the patient underwent hardware removal.During the procedure, a slide/fixed hammer fell off the handle.Another slide/fixed hammer was used to finish the case.The procedure was successfully completed with no surgical delay.The patient's status is unknown.This complaint involves one (1) device.This report is for (1) slide/fixed hammer 700 grams.This is report 1 of 1 (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.H3, h4, h6- the slide/fixed hammer 700 grams (p/n: 03.010.056, lot #: 4720666) was returned and received at us cq.Upon visual inspection, it was observed that the zyl stift 4x18 component was missing in the device.The overall complaint was confirmed for the received device as a component in the device was missing.The alleged complaint condition may be caused due to this missing component.There is no indication that a design or manufacturing issue has caused the complaint condition as the device was in use over 15 years and hence the root cause cannot be determined.The potential cause could be due to device maintenance.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 history lot part number:03.010.056, synthes lot number: 4720666, supplier lot number: n/a, release to warehouse date: 04jun2004, expiration date: n/a, manufactured by synthes brandywine.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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.
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.H10 additional narrative: 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: 10460476
• Report Number: 2939274-2020-03824
• Device Sequence Number: 16948423
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2020

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: 4720666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/16/2020; 09/22/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/21/2020; 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1