MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFRAME HALF RING; LAMP, OPERATING-ROOM

Catalog Number	387.337
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the synframe sent had a damaged part on it.The synframe has a large ring which is held together by screws on its diameter.There is an issue with the locking screws that means the ring was not stable during use.No patient involvement reported.This report is for one (1) synframe holding ring two-piece.This is report 1 of 1 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, h4, h6: the visual inspection of the returned synframe half ring has shown that the locking screw is damaged at the threaded shaft as well the hexagonal recess is badly widened.All in all the device is in very used condition and there are wear marks and scratches visible all over the surface.A functional test cannot be performed of the detected damage.The damaged thread of the locking screw prevent a proper tightened of the connection with the other synframe half ring.The received condition agree with the complaint description and the complaint therefore is confirmed.The investigation has shown that the locking screw is damaged at the threaded shaft as well the hexagonal recess is badly widened.All in all the device is in very used condition and there are wear marks and scratches visible all over the surface.The damaged thread of the locking screw prevent a proper tightened of the connection with the other synframe half ring.The damage incurred is determined to be post production.The damaged locking screw is a clear indication, that the product was used in an excessive way over the years.We do suppose that the cause of the damages are the result of a several mechanical overload situation during use.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part: 50131166, lot: 3043585, manufacturing site: hägendorf, release to warehouse date: 25.Nov.2008.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 or Problem Description
This report is for one (1) synframe half ring.This is report 1 of 2 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.

• Brand Name: SYNFRAME HALF RING
• Common Device Name: LAMP, OPERATING-ROOM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9847747
• Report Number: 8030965-2020-02042
• Device Sequence Number: 19018367
• Product Code: FQP
• UDI-Device Identifier: 07611819109223
• UDI-Public: (01)07611819109223
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K993314
• 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): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 387.337
• Device Lot Number: 3043585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/02/2020; 04/01/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 03/30/2020; 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNFRAME HOLDING RING Ø300 2PART CPL