MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL; APPLIANCE,FIXATION,NAIL

Catalog Number	390.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code lxt complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported on an unknown date that the patient underwent for an unknown surgery.During the surgery, one of clamp was broken.It was unknown if the procedure was completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) large ex-fix open adj clamp mr-conditional.This is report 1 of 1 (b)(4).
Additional 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 history lot part number:390.008, synthes lot number: 14l9174, supplier lot number: n/a, release to warehouse date: aug 19, 2019, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 or Problem Description
Updated event description: it was reported that during an unknown procedure while thumb tightening the ex-fix open adjusting clamp, a metal shard broke off from the thumb wheel and caused a sharps injury to the surgeon.Fragments were generated and successfully removed.The procedure was successfully completed.There was an unknown amount of surgical delay.

• Brand Name: LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10528208
• Report Number: 8030965-2020-06913
• Device Sequence Number: 19503032
• Product Code: KTT
• UDI-Device Identifier: 07611819760592
• UDI-Public: (01)07611819760592
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 390.008
• Device Lot Number: 14L9174
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention