MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI ELASTIC NAIL 440MM; PIN,FIXATION,SMOOTH

Model Number	475.920
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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, a titanium (ti) elastic nail was noted to be broken during reverse logistics audit of the returned devices at millstone.There were no patient and surgical involvement.This complaint involves one (1) device.This report is for one (1) handle with mini quick coupling.This is report 1 of 1 for (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.Part number: 475.920, lot number: h690689, part manufacturing date: 02 august 2018, manufacturing site: elmira, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h690689 of ti elastic nails was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the component device history record(s) determined the raw material lot h575755 met all specifications with no issues documented that would contribute to this complaint condition.Visual inspection: the 2.0mm ti elastic nail 440mm (p/n 475.920 lot h690689) was received showing a portion of the most distal end broken off and missing.It is clearly sheared off and thus, the complaint condition is confirmed.Device failure/ defect identified? yes.Dimensional inspection the ø 2.0 +0.03 / -0.07 mm of the nail proximal to the breakage got measured.Drawing: titanium elastic nail diameter: ø 2.0 +0.03 / -0.07 mm caliper: ca 215p measured diameter = ø 2.02 mm conclusion: the measuring result does show conformity.No product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Document/ specification review: the following drawing(s) was reviewed: titanium elastic nail a manufacturing record evaluation revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Complaint confirmed? yes.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: 2.0MM 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: 9184201
• Report Number: 2939274-2019-61480
• Device Sequence Number: 2811753
• Product Code: HTY
• UDI-Device Identifier: 10886982234537
• UDI-Public: (01)10886982234537
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 475.920
• Device Catalogue Number: 475.920
• Device Lot Number: H690689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1