MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS; GAUGE,DEPTH

Model Number	357.402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: visual inspection: the locking bolt measuring device f/trochanteric fixation nails (p/n: 357.402, lot #: 4595127) was received at us cq.Upon visual inspection, the ball and spring components were missing.Document/specification review: no design issues or discrepancies were identified.Dimensional inspection: dimensional inspections relevant to this complaint were not performed at due to a definitive finding of a missing component.Conclusion: the overall complaint was not confirmed for the locking bolt measuring device f/trochanteric fixation nails (p/n: 357.402, lot #: 4595127) as the device is missing the ball and spring components but is not 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.No design issues were observed during the document/specification review.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: part # 357.402, synthes lot # 4595127, supplier lot # na, release to warehouse date: 23 may 2003, manufactured by (b)(4), no ncr's were generated during production.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 two (2) 1.6mm guide wire 410mm do not function and one (1) locking bolt measuring device f/trochanteric fixation nails was broken during reverse logistics audit of returned device at millstone.There was no patient involvement.This is report 3 of 3 for (b)(4).

• Brand Name: LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS
• Common Device Name: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9643929
• Report Number: 2939274-2020-00525
• Device Sequence Number: 11374919
• Product Code: HTJ
• UDI-Device Identifier: 10886982196255
• UDI-Public: (01)10886982196255
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 357.402
• Device Catalogue Number: 357.402
• Device Lot Number: 4595127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1