MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION HANDLE FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Model Number	03.010.440
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
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) insertion handle for suprapatellar.This is report 2 of 2 for complaint (b)(4).
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.
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: part: 03.010.440-us, lot: 190164-101, manufacturing site: selzach, release to warehouse date: january 05, 2018, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the insertion handle for suprapatellar was received at us customer quality (cq).Visual inspection of the complaint device showed no defect.Functional test: the complaint device was assembled with the retuned connection screw.No issue was observed.As the other applicable mating devices were not returned, a full functional assessment was not able to be performed.Dimensional inspection: no dimensional inspection was performed due to the nature of the complaint.Also there was no defect pertaining to the device.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 damage or issue observed that could have contribute to the reported allegation.Also the device received was not assembled or unable to be separated from mating device.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: INSERTION HANDLE FOR SUPRAPATELLAR
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12617953
• Report Number: 2939274-2021-06011
• Device Sequence Number: 1415078
• Product Code: JDS
• UDI-Device Identifier: 10886982068828
• UDI-Public: (01)10886982068828
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• 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: 03.010.440
• Device Catalogue Number: 03.010.440
• Device Lot Number: 190164-101
• 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: 11/12/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2018
• 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; CANN CONNECTING SCR F/PERCUTAN INSTS NL; UNK - NAILS
• Patient Age: 31 YR
• Patient Sex: Unknown