MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.146
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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
It was reported that on (b)(6) 2021, during a procedure, after doing a tibial nail, the connecting screw was very difficult to loosen from the tibial nail.Eventually the nail was disconnected and the procedure was successfully completed.There was a (5) minutes of surgical delay noted.No patient consequences noted.This report is for (1) cann connecting scr w/internl thrd f/percutan insertn handle.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.Visual inspection: the cann cnct scr intnl thrd perc insrn hndl (part# 03.010.146, lot# u257749) was returned and received at us cq.Upon visual inspection at cq, it is observed that the distal threads of the device were stripped no other issues were observed with the returned device.Functional test: a functional assessment was not able to perform on the complaint device since the relevant mating device was not retuned.However, the condition of the threaded tip could have contributed to the device interaction issue.Dimensional inspection: drawing: 03_010_146 rev c feature: distal tip diameter specification: 8 mm +/-0.03 mm measured dimension: 7.98 mm result: conforming measurement device: caliper ca122p.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed cannulated connecting screw, 03_010_146 rev e/c (current and manufactured) no design issues or discrepancies were identified.Investigation conclusion: the overall complaint was confirmed.The potential cause for the device interaction condition could be due to the stripped threads.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.Device history lot - product code #: 03.010.146 , synthes lot #: u257749, supplier lot #: u257749, released to warehouse: 11apr2017/ 20apr2017/ 11aug2017, supplier: (b)(4).No ncrs were generated during production.Device history review - 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: CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE
• 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: 12788458
• Report Number: 2939274-2021-06604
• Device Sequence Number: 3874370
• Product Code: FZX
• UDI-Device Identifier: 10886982067968
• UDI-Public: (01)10886982067968
• 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
• 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): 10/16/2021

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: 03.010.146
• Device Catalogue Number: 03.010.146
• Device Lot Number: U257749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• 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: EXPERT TN Ø12 CANN L390 TAN LIGHT GREEN
• Patient Age: 19 YR
• Patient Sex: Male