MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: VA LOCKING; SCREW, FIXATION, BONE

Device Problems Use of Device Problem (1670); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

It was reported that while using the aiming arm on a va condylar plate, the surgeon placed a locking screw in a non locking hole.He said that he thought he had the trocar positioned in the locking location on the handle, however the screw went into the wrong hole.The surgeon elected to leave the screw in the hole and the surgery was successfully completed.Additionally the surgeon drill the fixed distal locking hole using variable angle technique and the screw head did not seat properly.No surgical delay was reported.There were no adverse consequence/s that affected the patient because of the reported event.Patient status/ outcome: stable.This report is for one (1) unk - screws: va locking.This is report 2 of 2 for complaint (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown unk - screws: va locking/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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: UNK - SCREWS: VA LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15500866
• MDR Text Key: 301277392
• Report Number: 8030965-2022-07414
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 122 KG