MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM TI ELASTIC NAIL 440MM; PIN, FIXATION, SMOOTH

Model Number	475.925
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 that on (b)(6) 2019, two titanium elastic nail was found broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves two (2) devices.This is 1 of 2 for report (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.Visual inspection: the 2.5mm ti elastic nail 440mm (p/n 475.925 s/n 11l3767) was received at customer quality, and upon visual inspection, it was observed that a portion of the nail was broken off and missing.It is clearly sheared off and thus, the complaint condition is confirmed.Device failure/ defect identified? yes.Dimensional inspection: the shaft ø 2.5 mm of the nail proximal to breakage got measured.Diameter: d = ø 2.5 +0.03 /- 0.07mm.Caliper: ca 818.Measured rod diameter = ø 2.49 mm.Conclusion: the measuring result does show conformity.The design, materials and finishing processes were found to be appropriate for the intended use of this device.Document/ specification review: relevant drawing(s) was reviewed: a review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformances were identified.Complaint confirmed? yes.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.5mm ti elastic nail was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.The lot quantity met all-dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the device history record for the raw material revealed no complaint related anomalies the device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation conclusion: a definitive assignable root cause for the post-manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.5MM TI ELASTIC NAIL 440MM
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9285822
• Report Number: 2939274-2019-61989
• Device Sequence Number: 19447922
• Product Code: HTY
• UDI-Device Identifier: 10886982234551
• UDI-Public: (01)10886982234551
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K971783
• 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): 10/19/2019

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: 475.925
• Device Catalogue Number: 475.925
• Device Lot Number: 11L3767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 10/19/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/11/2019
• Patient Sequence Number: 1