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

Catalog Number	390.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code lxh.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is sales representative.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.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 reports an event in (b)(6) as follows: it was reported that on an unknown date, an extra-wound anchorage was applied for foot joint surgery.During the surgery, the surgeon used four (4) large open adjustable clamp and four (4) large combination clamp were both in question in accordance with the surgical technique.The clip parts of all clamps did not hold other instruments well while the nuts of the clamps were fully untightened.The surgeon stated that he could not connect the instruments smoothly.The fixation was successfully obtained using the reported devices and the surgery was completed without other problem.It is unknown if there was surgical delay.Patient status was stable.This is report 7 of 8 for (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 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.
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 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 COMBINATION 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: 8740220
• Report Number: 8030965-2019-65817
• Device Sequence Number: 2566029
• Product Code: KTT
• UDI-Device Identifier: 07611819758414
• UDI-Public: (01)07611819758414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2019

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: 390.005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/23/2019; 08/26/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/23/2019; 08/26/2019
• Patient Sequence Number: 1