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
The locking bolt measuring device f/trochanteric fixation nails (p/n: 357.402, lot number: 4378076) was received at us cq.Visual inspection of the complaint device showed the device tip was bent and deformed.This complaint is not confirmed as the device is bent/deformed but not broken.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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 lot: part # 357.402.Synthes lot # 4378076.Supplier lot # na.Release to warehouse date: 12 jun 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.
Event or Problem Description
It was reported on (b)(6) 2020, that one depth gauge for locking screws did not function and another was broken.All the five (5) locking bolt measuring devices were found broken during the reverse logistics audit of the returned device at millstone.There was no patient involvement and no additional information is available.This report is for one (1) locking bolt measuring device f/trochanteric fixation nails this is report 3 of 4 for (b)(4).
Event or Problem Description
It was reported on january 8, 2020, two (2) depth gauge for locking screws, one does not function with lot number 7869711 and the other lot number 5411870 was broken, and all the three (3) locking bolt measuring devices that were also broken during the reverse logistics audit of the returned device at millstone.There was no patient involvement and no additional information is available.
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: updated data-b5.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: 9653419
• Report Number: 2939274-2020-00586
• Device Sequence Number: 2824915
• Product Code: HTJ
• UDI-Device Identifier: 10886982196255
• UDI-Public: (01)10886982196255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• 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: 4378076
• 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: 02/06/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1