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

Model Number	359.218
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Visual inspection: the hammer guide f/ten (p/n:359.218, lot #: 9513130) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the distal threads of the device were broken.There were scratches on the device and the etch was unreadable which has no impact on the functionality of the device.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Documentation/ specification review: the following drawing(s) was reviewed; elastic nail.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: visual inspection and document specification review of the received device was performed at cq.The complaint is being confirmed as it is observed that the distal threads of the device were broken.While a definitive root cause could not be determined, it is possible that the device might have got encountered unintended forces.During the investigation, no unidentified product design/manufacturing issues or discrepancies 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.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
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that the threads of the hammer guide are worn down and it can¿t screw into the dedicated hole.It cannot connect to the matching handle.This report is for one hammer guide for ti elastic nails.This is report 1 of 1 for (b)(4).

• Brand Name: HAMMER GUIDE FOR TI ELASTIC NAILS
• 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: 9670432
• Report Number: 2939274-2020-00638
• Device Sequence Number: 14174100
• Product Code: FZY
• UDI-Device Identifier: 10886982197207
• UDI-Public: (01)10886982197207
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 359.218
• Device Catalogue Number: 359.218
• Device Lot Number: 9513130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1