MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; SCREW, FIXATION, BONE

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.This report is for one (1) unknown trauma screw/unknown lot.Part and lot number are unknown; udi number is unknown.Date of original implant is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter phone number is not provided for reporting.The (510k): unknown, as specific part and lot numbers for screw is not provided.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that original surgery was performed for distal radius fractures on an unknown date.The screw head of an unknown screw, which had been fixed on the most distal side, became stripped during explant surgery on (b)(6) 2018.The surgeon tried every possible means to remove the stripped screw with extraction screw, which all failed.Finally, the surgeon cut off the screw head and removed the fragment with a reamer and an extraction bolt.The surgery was completed by over a 30-minute surgical delay.There was no adverse consequence to the patient.Procedure was completed successfully.This report is for one (1) unknown trauma screw.This is report 1 of 1 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.Event: included plate in description and as concomitant device.Concomitant medical products: this field is now applicable.Device evaluated by mfr, adverse event problem: 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

During extraction, the surgeon cut the plate to remove the stripped screw.No fragment was reported.Concomitant devices: 2.0mm titanium variable angle locking (val) phalangeal base plate-2h head-6 hole shaft-sterile (part: 04.130.354s, lot: 9917654, quantity: 1).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7535079
• MDR Text Key: 109012222
• Report Number: 8030965-2018-53922
• 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: 05/01/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention