MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFRAME RETRACTOR HOLDER- ADJUSTABLE; MISC ORTHO SURGICAL INSTR

Catalog Number	387.361
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not distributed in the united states but is similar to device marketed in the usa.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Without a lot number, the device history records review could not be completed as no product was received.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 on an unknown date that the synframe retractor holder- adjustable was not functioning.It was unknown if surgery delayed and patient was involved or not.This is report 1 of 3 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.H3, h6: part: 387.361, lot: 2398905, manufacturing site: bettlach, release to warehouse date: august 14, 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection has shown that returned device is all in all in used condition.There are wear marks and scratches visible on the surface.Additionally, the set screw, which is slightly caulked, was tried to turned out.The loosening of the screw has damaged the threaded part section which has finally let to jam up the screw.It cannot be excluded that this has led to the blocked mechanism due to small generated fragments in the mechanism.Functional test: a functional check was performed, and it was not possible to unlock the mechanism to release the bracket.Therefore the instrument does not work as intended anymore.Dimensional inspection: based on the age of the instrument and due to the post manufacturing damages at the instrument no dimensional inspection will be performed.Document / specification review the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the visual inspection has shown that returned device is all in all in used condition.There are wear marks and scratches visible on the surface.Additionally, the set screw, which is slightly caulked, was tried to turned out.The loosening of the screw has damaged the threaded part section which has finally let to jam up the screw.It cannot be excluded that this has led to the blocked mechanism due to small generated fragments in the mechanism.This lot was manufactured in august 2008 according to the specification.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Unfortunately, we are not able to determine the exact cause which has let to this occurrence, we can only assume that the removal of the set crew has created some small fragments which have led to the blocked mechanism.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 RETRACTOR HOLDER- ADJUSTABLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9525708
• Report Number: 8030965-2019-71503
• Device Sequence Number: 2695587
• Product Code: LXH
• UDI-Device Identifier: 07611819238992
• UDI-Public: (01)07611819238992
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 12/04/2019

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: 387.361
• Device Lot Number: 2398905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1