MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.0MM/3.0MM CONNECTING CLAMP; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 395.133

Device Problems Device-Device Incompatibility (2919); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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 reports an event in (b)(6) as follows: it was reported that on an unknown date, while performing a review of the falange minifixer system, it was evident that the system bars did not enter the patella properly.The system is blocked for operation due to incomplete key pieces.No further information provided.Concomitant devices reported: 3.0mm/3.0mm connecting clamp (part# 395.133, lot# unknown, quantity# 2), holding clamp 1.25mm (part# 395.125, lot# unknown, quantity# 2), holding clamp 1.6mm (part# 395.126, lot# unknown, quantity# 1).This is report 4 of 5 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.D10: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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

Concomitant devices reported: 3.0mm/3.0mm connecting clamp (part 395.133, lot l594154, l234175, l344165, l234175, 8577693, quantity 5), holding clamp 1.25mm (part 395.125, lot l639570, l671743 (x2), l716619, 1358912, l805743, quantity 6), holding clamp 1.6mm (part 395.126, lot 1362940 (x2), l082894, l1362940, l858755, l797231 (x2), quantity 7).This is report 4 of 10 for (b)(4).Additional devices for this event are captured on related complaints (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.

• Brand Name: 3.0MM/3.0MM CONNECTING CLAMP
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9860303
• MDR Text Key: 191425965
• Report Number: 8030965-2020-02134
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819201484
• UDI-Public: (01)07611819201484
• Combination Product (y/n): N
• PMA/PMN Number: K971987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 395.133
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 01/31/2021
• Patient Sequence Number: 1
• Treatment: CONNEC-CLAMP Ø3 F/MINI-EXT-FIX; CONNEC-CLAMP Ø3 F/MINI-EXT-FIX; CONNEC-CLAMP Ø3 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX