MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI RECON SCREW W/T25 STARDRIVE 55MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.031.021S

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported during a procedure on (b)(6) 2020 several issues occurred intraoperatively which included device malfunctions, and missing implant components.The surgeon noted the main implants were missing associated locking screws.Some of the screw lengths were on back-order, however, there were other lengths of screws in the set additionally, the long t25 screwdriver was worn, and would not engage the recess of the screws well.The connecting screw for the nail was worn out and did not connect to the implant properly.Also, during the surgery, the surgeon used the aiming guide to drill for the proximal screws.Once the screws were implanted, an x-ray was taken and it was noted that the screws missed the nail.The surgery was delayed 60 minutes, and the procedure was completed using a competitor's nail.This is report 3 of 7 (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.

• Brand Name: 5.0MM TI RECON SCREW W/T25 STARDRIVE 55MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10684452
• MDR Text Key: 211505196
• Report Number: 8030965-2020-07949
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819303584
• UDI-Public: (01)07611819303584
• Combination Product (y/n): N
• PMA/PMN Number: K070843
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.031.021S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Patient Sequence Number: 1
• Treatment: AIM-ARM F/EXPERT ALFN; CONNECSCR CANN F/EXPERT TN+FN F/03.010.0; LOCKSCR Ø4 L66 F/NAILS TAN DBLUE; SCRDRIVER T25 L380; UNK - NAILS; UNK - SCREWS: TRAUMA; AIM-ARM F/EXPERT ALFN; CONNECSCR CANN F/EXPERT TN+FN F/03.010.0; LOCKSCR Ø4 L66 F/NAILS TAN DBLUE; SCRDRIVER T25 L380; UNK - NAILS; UNK - SCREWS: TRAUMA