MAUDE Adverse Event Report: SYNTHES GMBH HOLDING SLEEVE-LONG FOR MATRIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.632.036
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that a dr.Was performing a matrix lumbar fusion and upon inserting the sacro-iliac screws, the screwdriver retaining sleeve broke at the distal end tip.The end threads became undone,.The nurse discarded the sleeves.It was also reported that nothing fell into the patients, as there were no delays during the surgery and the short retaining sleeves were used for the remainder of the case.There is no more information to provide.Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for one (1) holding sleeve-long for matrix.This report is 1 of 2 for (b)(4).

• Brand Name: HOLDING SLEEVE-LONG FOR MATRIX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12099865
• Report Number: 8030965-2021-05476
• Device Sequence Number: 19887377
• Product Code: LXH
• UDI-Device Identifier: 07611819379435
• UDI-Public: (01)07611819379435
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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 Catalogue Number: 03.632.036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1