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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 on (b)(6) 2020, one (1) helical blade inserter, six (6) locking bolt measuring device and two (2) depth gauge for locking screw were broken and one (1) helical blade inserter does not function during reverse logistics audit of the returned device at millstone.There was no patient involvement.This is a report for (1)locking bolt measuring device f/trochanteric fixation nails.This is report 9 of 09 (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.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the locking bolt measuring device f/trochanteric fixation nails (part # 357.402, lot number # 4586518) was received at us cq.Visual inspection of the complaint device showed the needle was minorly bent.The overall complaint was not confirmed as there was no evidence of physical device breakage.Document/specification review: (current and manufactured).No design issues or discrepancies were identified.Investigation conclusion: the overall complaint was not confirmed for the received locking bolt measuring device f/trochanteric fixation nails as the needle was bent and there was no evidence of device breakage.Although no definitive root-cause can be determined, its possible the device experienced unintended forces while in use/storage.No manufacturing or design issues were identified during the document 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.H3, h4, h6: a device history record (dhr) review was conducted: part # 357.402; synthes lot # 4518716; supplier lot # na; release to warehouse date: 09 dec 2002; manufactured by synthes brandywine.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, 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.

• 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: 9642662
• Report Number: 2939274-2020-00516
• Device Sequence Number: 1965467
• 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,Followup
• 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: 4518716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1