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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary background: libertas: it was reported on (b)(6) 2020, one (1) locking bolt measuring device was broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) device.Device history lot device history lot part number:357.402 synthes lot number: 4827582 supplier lot number: n/a release to warehouse date: 04aug2004 expiration date: n/a manufactured by synthes (b)(4).No ncrs were generated during production.Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation flow: damage visual inspection: the locking bolt measuring device f/trochanteric fixation nails (p/n: 357.402, lot #: 4827582) was returned and received at us cq.Upon visual inspection, it was observed that the slider assembly was missing the ball 2.5 dia component.The needle component is slightly bent.No other issues were observed with the returned device.Device failure/ defect was found.Dimensional inspection: there was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed locking bolt measuring device: 357_402, rev.F/c slider assembly: 367_402_2, rev.E/d complaint was confirmed.The device received was missing a component.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the locking bolt measuring device f/trochanteric fixation nails (p/n: 357.402, lot #: 4827582).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to device maintenance.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 (b)(6) 2020, one (1) locking bolt measuring device was broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.Concomitant device reported: lockg blt meursng dvce f/trochanteric fixation nls, (lot #h299833 & qty unknown) this complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint (b)(4).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: h11: g4 provided for reporting.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.G4.

• 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: 11229695
• Report Number: 2939274-2021-00471
• Device Sequence Number: 3512222
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 4827582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 01/28/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKG BLT MEURSNG DVCE F/TROCHANTERIC FIXATION NLS