MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BEND-PLIER F/R Ø3.5+PL 3.5; BENDER

Catalog Number	03.614.022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
The flat spring bar broke off during rod bending.Nothing feel in the patient as this part was done on the side over a sterile table.The instrument is available for return, but the broken piece was discarded by hospital personnel.There is no surgical delay are reported.There was no patient involvement.Device report from synthes reports an event in country as follows: (b)(6).                                                                                                      concomitant devices reported: unknown rod (part# unknown, lot# unknown, quantity 1).This is report 1 for 1 (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.A product investigation was conducted.Visual inspection: the bend-plier f/r ø3.5+pl 3.5 (part # 03.614.022 lot # t159836) was received at us cq.The leaf spring of the device was broken, no fragments were returned.A portion of the leaf spring remained secured to the handle of the device, majority of the leaf spring broke off.The received condition is consistent with the complaint condition thus the complaint is confirmed.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Manufacturing record evaluation: the received bend-plier f/r ø3.5+pl 3.5 (part # 03.614.022 lot # t159836) was manufactured at the tuttlingen site on 23-jul-2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint was confirmed for the bend-plier f/r ø3.5+pl 3.5 (part # 03.614.022 lot # t159836) as the leaf spring of the device was broken.The leaf spring was broken such that a minimal portion of the leaf spring remained attached to the device.Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces during use.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 a device history record (dhr) review was conducted: part number: 03.614.022.Lot number: t159836.Manufacturing site: tuttlingen.Release to warehouse date: 23-jul-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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.

• Brand Name: BEND-PLIER F/R Ø3.5+PL 3.5
• Common Device Name: BENDER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9119642
• Report Number: 2939274-2019-60883
• Device Sequence Number: 19394085
• Product Code: HXW
• UDI-Device Identifier: 07611819968431
• UDI-Public: 07611819968431
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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 Catalogue Number: 03.614.022
• Device Lot Number: T159836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS