MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HOLDING CLAMP 1.6MM; BONE, PLATE

Model Number 395.126

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is company representative.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history: part: 395.126, lot: l797231, manufacturing site: (b)(4), release to warehouse date: 02 july 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 colombia as follows: it was reported during an inspection of the minifixer system, it is noted that the holding and connecting clamps do not function appropriately with the other devices.No patient involvement.This is report 8 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.H10: additional narrative: d10, h6.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.

Manufacturer Narrative

Product complaint # (b)(4).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.H3, 4, h6: device history lot device history lot part: 395.126, lot: l797231, manufacturing site: hägendorf, release to warehouse date: 02.July 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: background: performing a review of the falange minifixer system, it is evident that the system bars do not enter the patella properly.For now, the system is blocked for operation due to incomplete key pieces.395.133 * (b)(4) units, 395.125 * (b)(4) units, 395.126 * (b)(4) units.This complaint involves twenty-three (23) devices.Investigation flow: functional/device interaction.Visual inspection: the holding clamp ø1.6 f/mini-ext-fix (p/n: 395.126, lot number: l797231) was received at us cq.Visual inspection of the complaint device showed no damage or defects with the device.Functional test: complete functional testing of the device received was not performed at cq as the mating devices were not returned at cq.But all the components of the device were disassembled and assembled as intended without any issues.Can the complaint be replicated with the returned device(s)? unable to perform dimensional inspection: (gauge pins: gp32) dimensional inspection of the connecting rod hole in the clamp was performed at cq.The diameter of the hole of the clamp was measured and is within specification.Document/specification review: se_481563 rev b (current) and rev a (manufactured) were reviewed.Se_437444 rev c (current) and rev b (manufactured) were also reviewed.No design issues or discrepancies were identified.Complaint was not confirmed.Investigation conclusion: this complaint is not confirmed as no defects were identified and a full functional test could not be performed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: HOLDING CLAMP 1.6MM
• Type of Device: BONE, PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9986211
• MDR Text Key: 188666350
• Report Number: 8030965-2020-03021
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10886982200181
• UDI-Public: (01)10886982200181
• Combination Product (y/n): N
• PMA/PMN Number: K033158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2020

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
• Device Operator: Health Professional
• Device Model Number: 395.126
• Device Catalogue Number: 395.126
• Device Lot Number: L797231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 04/06/2021; 05/07/2021
• Supplement Dates FDA Received: 04/06/2021; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONNEC-CLAMP Ø3 F/MINI-EXT-FIX; CONNEC-CLAMP Ø3 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.25 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.6 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.6 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.6 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.6 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.6 F/MINI-EXT-FIX; HOLDING CLAMP Ø1.6 F/MINI-EXT-FIX