MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTER FOR TI ELASTIC NAILS; INSTRUMENT,CUTTING,ORTHOPAEDIC

Model Number	359.217
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
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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, the cutter for titanium elastic nails appeared to be broken.We were notified postoperatively, however, do not have any indication when this issue occurred.It is also unknown if there were any surgical delay.Procedure and patient outcome was unknown.This complaint involves one (1) device.This report is 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.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.
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.H3, h6: a product investigation was conducted.Visual inspection: the cutter for ti elastic nails (p/n 359.217, lot number 8888497) was received at us cq on november 21, 2019.Visual inspection of the complaint device showed a piece has sheared off from the swivel portion of the rotating component.The other components have no damage.Dimensional inspection: no dimensional inspection will be performed due to post manufacturing damage.Document/specification review:relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the component has a broken piece.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 359.217-us, lot: 8888497, manufacturing site: hägendorf, release to warehouse date: 31.Oct.2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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.H3, h6: customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s).Please note the image is of just one component of the cutter (12 nut doublehex-321.200.002).The image(s) (1 total) was reviewed and the complaint condition for broken could be confirmed as the image(s) showed a piece has sheared off from the swivel portion of the component.As the instrument(s) was not returned, an as received, dimensional, material, or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number in the image is for the component and not of the entire assembly and therefore, it could not be determined.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.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: CUTTER FOR TI ELASTIC NAILS
• Common Device Name: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8956718
• Report Number: 2939274-2019-60274
• Device Sequence Number: 328550
• Product Code: HTZ
• UDI-Device Identifier: 10886982197153
• UDI-Public: (01)10886982197153(
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/06/2019

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: 359.217
• Device Catalogue Number: 359.217
• Device Lot Number: 8888497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/06/2019; 11/21/2019; 12/02/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/19/2019; 11/29/2019; 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1