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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device received.A review of the device history record.Device history lot, part number: 03.010.056, synthes lot number: 4771166, supplier lot number: n/a, release to warehouse date: 05 oct 2004, expiration date: n/a, manufactured by synthes (b)(4).Investigation summary background: it was reported on an unknown date, during routine incoming inspection of a loaner set, it was observed that the slide hammer was broken.There was no patient involvement.This complaint involves (1) device.Flow: damage: visual inspection: the returned 14+ year old reusable hammer was examined at customer quality (cq) and the complaint condition was able to be confirmed as the device was received with broken pieces in the handle.Several fragments have been generated.The remainder of the instrument shows significant dents, wear marks and impact marks.Device failure / defect identified: dimensional inspection: a dimensional analysis of the handle was not performed at customer quality (cq).There is no indication that dimensions would suddenly cause the 14+ year old reusable hammer handle to crack.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis was able to be completed due to post-manufacturing damage.Document/ specification review: relevant drawings for the returned instrument were reviewed: (b)(4).Mrr (b)(4) was generated during production for 1 part with scuff mark on od, and 2 parts with excessive heat that stain.All 3 parts were returned and scrapped.This non-conformance is not relevant to the complaint condition since it is not related to after washing at the sterile processing department wooden handle of slide/fixed hammer broke/split.Investigation conclusion: during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.It is most likely that 14 years of use and repeated thermal sterilization cycles has contributed to the handle breaking.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.
Event or Problem Description
It was reported on an unknown date, during routine incoming inspection of a loaner set, it was observed that the slide hammer was broken.There was no patient involvement.This complaint involves (1) device.This report is 1 of 1 for (b)(4).

• 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: 8833718
• Report Number: 2939274-2019-59417
• Device Sequence Number: 310934
• Product Code: FZY
• UDI-Device Identifier: 10886982067289
• UDI-Public: (01)10886982067289
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 07/01/2019

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: 03.010.056
• Device Catalogue Number: 03.010.056
• Device Lot Number: 4771166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1