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

Catalog Number	399.43
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 three (3) 700gram hammers are leaving greasy residue.There was no patient involvement.This report is for a hammer 700 grams.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Part 399.430, lot 9856772: manufacturing site: (b)(4).Release to warehouse date: april 21, 2016.The device history record (dhr) shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was completed: the returned instrument was examined and there is no evidence of greasy residue coming out of the handle/shaft interface.The balance of the device is in worn condition with impactions marks along the hammer portion of the device.The received condition does not agree with the complaint description.A device history review, was performed for the returned implant¿s lot number and no material review reports (mrrs), non-conformance reports (ncrs) or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Relevant drawings for the returned device were reviewed.There is no visual evidence or tangible evidence on the returned hammer that confirms the reported condition.A definitive root cause for the reported complaint condition could not be determined because the complaint could not be confirmed.It is possible that the specific sterilization procedure at the reporting hospital has contributed to the reported event and subsequent decontamination of the device at synthes monument site has removed all evidence of the reported condition.However, this cannot be definitively confirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.
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.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.The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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.

• Brand Name: 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: 7508626
• Report Number: 2939274-2018-52147
• Device Sequence Number: 11265511
• Product Code: FZY
• UDI-Device Identifier: 10886982202819
• UDI-Public: (01)10886982202819
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2018

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 Catalogue Number: 399.43
• Device Lot Number: 9856772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 05/17/2018; 06/18/2018; 07/13/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/06/2018; 07/03/2018; 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1