MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT; MISC ORTHO SURGICAL INSTR

Model Number	387.358
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.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 product was received; 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
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2021 that the patient underwent for an unknown surgery.During the surgery, it was notice that the retractor blades were not fitting into the guide rods properly.It was unknown if the surgery completed successfully.There were no patient consequences.Concomitant device reported: unknown retractor blades (part: unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) synframe guide rod w/adjust-clamp f/soft.This is report 1 of 1 (b)(4).
Event or Problem Description
This is report 2 of 2 (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: d7 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.B5.

• Brand Name: SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11360650
• Report Number: 2939274-2021-00998
• Device Sequence Number: 4069154
• Product Code: LXH
• UDI-Device Identifier: 10705034771168
• UDI-Public: (01)10705034771168
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 387.358
• Device Catalogue Number: 387.358
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 04/09/2021
• 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: SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT; UNK - RDUCTN/RTRACTN/DSTRACTN INSTRUS: TRMA; SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT; UNK - RDUCTN/RTRACTN/DSTRACTN INSTRUS: TRMA