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

Catalog Number UNK - SCREWS: LOCKING: TRAUMA

Device Problems Use of Device Problem (1670); Device Difficult to Maintain (3134)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unknown screw locking/unknown lot number.Without the specific part number, the udi number and 510k number is 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 as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the patient underwent a surgery for proximal ulna with the locking screws in question and the plate.The patient underwent a removal surgery on (b)(6) 2019.In the reoperation, the locking screws could not be removed because their head got worn out.The surgeon used a carbide drill and a surgical bur to detach the plate and the screws.The screws (approximately 3 screws, the exact number of remained screws is not confirmed) remained in the patient body.The surgery was delayed by less than 30 minutes.No further information is available.Concomitant devices reported: va-lcp prox ulna pl 2.7/3.5 r 12ho l211(part# 04.107.412s, lot# unknown, quantity# 1).This complaint involves an unknown number of devices.This report is 3 of 3 for (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.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 Description

Updated event: extraction of screws was done because the bone union was confirmed.Scheduled surgery time was for one (1) hour.Surgery was extended by approximately two (2) hours.Concomitant devices reported: va-lcp prox ulna pl 2.7/3.5 r 12ho l211(part# 04.107.412s, lot# unknown, quantity# 1), unknown screws: trauma (part# unknown, lot# unknown, quantity# unknown).

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9448947
• MDR Text Key: 194761791
• Report Number: 8030965-2019-71010
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREWS: LOCKING: TRAUMA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2019
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA; VA-LCP PROX ULNA PL 2.7/3.5 R 12HO L211; VA-LCP PROX ULNA PL 2.7/3.5 R 12HO L211
• Patient Age: 22 YR