MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.404
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has been 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) 2021, during the insertion of the nail, the targeting arm, static arm screw was not able to insert in the nail so it had to be removed and insert manually.Upon removal of the insertion handle from the nail, the surgeon could not get the insertion bolt out of the nail.Hammer was used to remove the insertion handle.Procedure outcome and patient status are unknown.This report is for one (1) cann connecting scr f/percutan instruments for nails-ex.This is report 1 of 2 for complaint (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.H10 additional narrative: h3, h6: part: 03.010.404, synthes lot: u357728, supplier lot: u357728, release to warehouse date: april 28, 2020, supplier: (b)(4), no nonconformance reports (ncrs) were generated during production.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.Visual inspection: the cann connecting scr f/percutan insts nl was received at us customer quality (cq).Visual inspection of the complaint device showed showed only surface scratches due to the usage of the device.Functional test: the device was able to be assembled with the returned insertion handle for suprapatellar.No issue was observed.A full functional assessment was not able to be performed as all applicable mating component(s) were not returned.Dimensional inspection: measured dimension: shaft od = conform, head od = conform.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as there was no defect observed that could have contributed to the reported allegation.No root cause could definitively be determined for the reported complaint condition.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 preventive 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.

• Brand Name: CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12617938
• Report Number: 2939274-2021-06010
• Device Sequence Number: 1415077
• Product Code: FZX
• UDI-Device Identifier: 10886982068569
• UDI-Public: (01)10886982068569
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 03.010.404
• Device Catalogue Number: 03.010.404
• Device Lot Number: U357728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - NAILS
• Patient Age: 31 YR
• Patient Sex: Unknown