MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRILL/TAP AND SCREW GUIDE WITH POST; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.613.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2020, the surgeon placed the guide in the hole of the plate and attempted to seat it.There was a little trouble doing this however, the pin was seated in the hole of the plate and four (4) screws were placed.As the surgeon lifted the guide out of the last place, the pin got stuck and had to be removed with forceps.The procedure was completed successfully with a delay of five (5) minutes.Concomitant devices: plate (part: unknown, lot: unknown, quantity: 1), screws (part: unknown, lot: unknown, quantity: unknown) this report is for a drill/tap and screw guide with post.This is report 2 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.H3, h6: part: 03.613.001, lot: 3232903, manufacturing site: hägendorf, release to warehouse date: august 13, 2009.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 the position pin of the drill and screw guide is fell apart.For further investigation the position pin is not available.Functional test: a functional test can not be performed of the detected damage.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.This drill and screw guide was made from the sub-component 50163188.The component is not lot tracked.Therefore, the last three potential work orders that were produced prior to lot 3232903 were reviewed.The review has shown that with 1.4542 the correct material was used, and the hardness value was confirmed to meet the specification with no non-conformance noted.Summary: the received condition agree with the complaint description and the complaint therefore is confirmed.The investigation of the complained instrument shows that the position pin of the drill and screw guide is fell apart and not returned.We have to assume, that high applied mechanical forces caused the breakage of the spot welding and therefore the position pin got loose.Please note, this is rather old and often used instrument.This product was manufactured in august 2009 and is now more than 11 years old.By the evidence, that the device passed our 100% final inspection before the device left the manufacturing site we confirm that the cause of failure is not due to any manufacturing non-conformance's.The present article has shown that spot welding are visible on the surface which connected the position pin as intended.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 customer quality (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 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.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
Concomitant devices reported: screws (part: unknown, lot: unknown, quantity: unknown); drill/tap and screw guide with post (03.613.001, lot number: 3111809, quantity: 1), plate (part: unknown, lot: unknown, quantity: 1).

• Brand Name: DRILL/TAP AND SCREW GUIDE WITH POST
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10009241
• Report Number: 8030965-2020-03176
• Device Sequence Number: 14177501
• Product Code: FZX
• UDI-Device Identifier: 07611819790766
• UDI-Public: (01)07611819790766
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 03/02/2020

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: 03.613.001
• Device Lot Number: 3232903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 05/05/2020; 05/17/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/14/2020; 05/18/2020
• 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: DRILL+SCRGUIDE F/VECTRA+VECTRA-T; UNK - PLATES: SPINE; UNK - PLATES: SPINE; UNK - SCREWS; UNK - SCREWS; UNK - PLATES: SPINE; UNK - SCREWS