MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ADJUSTABLE WIRE/PIN CLAMP; APPLIANCE,FIXATION,NAIL

Catalog Number 393.464

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 08/20/2020

Event Type  Injury  

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.(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)(4) reports an event as follows: it was reported that on (b)(6) 2020 that the orthokit set wasn't compatible for the surgery as expected.The description of the set did not align with the operating technique.The patient was already in narcosis and prepared for surgery but had to be waken up without any intervention.Therefore patient is still waiting for treatment.On (b)(6) 2020 it was determined that the orthokit used is named "hybrid ring fixator set".Changes were made to the orthokit because the hybrid ring fixator articles are obsolete however, no communication was made in terms of the articles being obsolete and about the changes in the orthokit.The articles in the orthokit as it is now, have nothing to do with the hybrid-ring-fixator, except the parts for the large external fixator.They are part of the distractor osteogenesis.The articles are obsolete and it isn¿t possible to do a hybrid-ring fixator surgery anymore.This report is for one (1) adjustable wire/pin clamp.This is report 1 of 10 for (b)(4).This complaint is linked to (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: ADJUSTABLE WIRE/PIN CLAMP
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10535502
• MDR Text Key: 213876329
• Report Number: 8030965-2020-06972
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K962484
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 393.464
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Patient Sequence Number: 1
• Treatment: BACK-UP WIRE TIGHTENER F/HYBRID RING-FIX; FULL-RING I-Ø 115; FULL-RING I-Ø 115; PROTECT SLEEVE SLOTTED F/SCHANZ SCR-Ø5; PROTECT SLEEVE SLOTTED F/WIRES Ø1.8-2; RING-TO-ROD CLAMP F/HYBRID RING-FIX; RING-TO-ROD CLAMP F/HYBRID RING-FIX; RING-TO-ROD CLAMP F/HYBRID RING-FIX; RING-TO-ROD CLAMP F/HYBRID RING-FIX; WIRE/PIN-TO-RING CLAMP; WIRE/PIN-TO-RING CLAMP; WIRE/PIN-TO-RING CLAMP; WIRE/PIN-TO-RING CLAMP; WIRE/PIN-TO-RING CLAMP; WIRE/PIN-TO-RING CLAMP; WIRE/PIN-TO-RING CLAMP; WIRE/PIN-TO-RING CLAMP; WIRE/PIN-TO-RING CLAMP; WIRETIGHTENER; ¾-RING I-Ø 140; ¾-RING I-Ø 140; ¾-RING I-Ø 165; ¾-RING I-Ø 165; ¾-RING I-Ø 205; ¾-RING I-Ø 205
• Patient Outcome(s): Required Intervention