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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: there is no patient involvement.Additional procode: lxt.Device was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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 synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, two clamps experienced a holding failure.There was no patient involved.This report is for a large ex-fix open adj clamp mr-conditional.(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.Initial reporter name and address: reporter¿s facility address.A device history record (dhr) review was conducted for part number: 390.008, lot number: 9871524 : date of manufacture: 06-aug-2015, place of manufacture: (b)(4), part expiration date: none, list of nonconformances: none: description of dhr review: no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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: 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: 7731277
• Report Number: 8030965-2018-55359
• Device Sequence Number: 19173790
• Product Code: KTT
• UDI-Device Identifier: 07611819760592
• UDI-Public: (01)07611819760592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 390.008
• Device Lot Number: 9871524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/17/2018
• Patient Sequence Number: 1