MAUDE Adverse Event Report: SYNTHES GMBH HOOK/SCREW HOLDER WITH 4.0MM HEX

Catalog Number	388.612
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from the (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the surgical team used a stalk to final tighten a screw and felt like it was about to snap.Another stalk was used instead for the remaining screws.The item has since been discarded.There was no patient impact or delay to surgery.This report is for a hook/screw holder with 4.0mm hex.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: HOOK/SCREW HOLDER WITH 4.0MM HEX
• Common Device Name: HOOK/SCREW HOLDER WITH 4.0MM HEX
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11769623
• Report Number: 8030965-2021-03532
• Device Sequence Number: 4061389
• Product Code: LXH
• UDI-Device Identifier: 07611819718432
• UDI-Public: (01)07611819718432
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 04/08/2021

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: 388.612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/04/2021
• 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: UNK - SCREWS