MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFRAME RING CLAMP; MISC ORTHO SURGICAL INSTR

Catalog Number 387.347

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.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 europe reports an event in (b)(6) as follows: it was reported the synframe ring clamp was not sufficiently holding its position during an unknown procedure on unknown date.Surgery was completed successfully with a delay of no more than 60 seconds.This report is for one (1) synframe ring clamp.(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.Device evaluated by mfr: a device history record review was performed for the subject device: part number: 387.347; synthes lot number: 8190219; release to warehouse date: 04 dec 2012; manufacturing site: hägendorf.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 condition.A product development investigation was performed for the subject device: investigation site: cq zuchwil.Selected flow: 2.Device interaction/functional.Visual inspection: the investigation has shown that the returned synframe clamp is in a very used condition.The blue color is abraded at the area where the retaining ring and guiding rod are mounted.It is also notable that the peripheral zones of the clamps show plastic deformations.Functional test / dimensional inspection: cannot be performed due to the damage incurred; however, dimensions and function were checked per 100% at the time of manufacturing with no issues documented.Drawing/specification review: the investigation confirmed that the damage of the synframe clamp is determined to be post-production/acceptance criterias, therefore no drawing/specification review is needed.Summary: the complaint condition is confirmed as the synframe clamp presents deformations preventing the clamp from proper functioning.The review of the device history record revealed that this clamp was manufactured in december 2012 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The clamp is made from aluminium alloy.The investigation found no manufacturing related issues that would have contributed to this complaint condition.The damage occurred is determined to be post production/acceptance criterias.Damage appears to be the result of repeated use and wear over the life of the device.During the investigation, no indication for a product design or manufacturing issue was identified that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.No ncr's were generated during production that would contribute to the 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.

• Brand Name: SYNFRAME RING CLAMP
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7501143
• MDR Text Key: 107829849
• Report Number: 8030965-2018-53661
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819141278
• UDI-Public: (01)07611819141278
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 387.347
• Device Lot Number: 8190219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1