MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFRAME LENGTHENER; LAMP, OPERATING ROOM

Catalog Number	387.338
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history record has been requested.The investigation could not be completed; 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
"the newly bought synframe extension cannot be connected to the synframe ring which is already available at the hospital.The issue was noted during assembly.No surgery was affected or no patient involvement." this report for one (1) synframe-extension f/387.336+387.337.This report is 2 of 2 for (b)(4).
Event or Problem Description
Updated ed: concomitant device reported: unknown synframe half ring (part# unknown; lot# unknown; quantity: 1).This complaint involves two (2) devices.
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.
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 investigation of this complaint has shown that the lot 4l53724 of synframe-extension 387.338 was incorrectly assembled during the manufacturing process.Due to this manufacturing error following actions were introduced and no further investigation for this complaint (b)(4) is required.Device history lot part: 387.338, lot: 4l53724, manufacturing site: haegendorf, release to warehouse date: 19.June 2019.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.

• Brand Name: SYNFRAME LENGTHENER
• Common Device Name: LAMP, OPERATING ROOM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9836798
• Report Number: 8030965-2020-01971
• Device Sequence Number: 1299779
• Product Code: FQP
• UDI-Device Identifier: 07611819109230
• UDI-Public: (01)07611819109230
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 387.338
• Device Lot Number: 4L53724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 06/16/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/10/2020; 06/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNFRAME-EXTENSION F/387.336+387.337; SYNFRAME-EXTENSION F/387.336+387.337; UNKNOWN SYNFRAME HALF RING