MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6.0MM LOCKING SCREW 60MM LENGTH; SCREW, FIXATION, BONE

Catalog Number SD601.060

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Device is a veterinary product.It is currently unknown if this was a veterinary procedure.Date of event is an unknown date in 2019.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on an unknown date, there were items missing from the set.There were no 60mm locking screws, no 65mm locking screws, and only one 75mm screw was present.The surgeon had to use other screws that were either too long or to short, hindering a stable fixation.Procedure was completed with an unknown delay.Concomitant devices: locking screws (part: unknown, lot: unknown, quantity: unknown), trauma screws (part: unknown, lot: unknown, quantity: unknown) this report is for a 6.0mm locking screw 60mm length.This is report 1 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.

• Brand Name: 6.0MM LOCKING SCREW 60MM LENGTH
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9847598
• MDR Text Key: 194634209
• Report Number: 8030965-2020-02039
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD601.060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 03/18/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention