MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SLIP SLEEVE FOR THREADED HOLDING SLEEVE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.614.036
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2020
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 on an unknown date that the patient was underwent for a posterior cervical spinal fusion in c1-c2 treating atlantoaxial subluxation on (b)(6) 2020.They had no issue on assembling the holding sleeve, the slip sleeve, the screwdriver shaft, and using the unit during the procedure.However, they were not able to disassemble those devices.The procedure was completed without surgical delay.The patient outcome was unknown.This complaint involves two (2) devices.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: a review of the device history record.Device history lot part number: 03.614.036, lot number: 8289568, manufacturing site: hägendorf, release to warehouse date: 19.Feb.2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary investigation selection investigation site: cq zuchwil, selected flow(s): device interaction/functional.Visual inspection: upon visual inspection of the complaint device it can be seen that the sleeve got received assembled to the hold-sl.In addition, the instrument shows some sings of use from use over the years but is otherwise in a good condition.Functional test: during investigation a functional test was performed, the sleeve was easily to disassemble from the hold-si.The instrument passed the functional test.Dimensional inspection: the article has passed the function test, no issue could be confirmed, and therefore no dimensional inspection is needed.Document/specification review: drawings and revisions are in accordance to dhr of production lot 8289568.All relevant features are defined on the used drawing revisions of dhr of production lot 8289568.Summary: we are not able to reproduce or confirm this incident, as the part is fully functional.Unfortunately we are not able to determine the exact reason for this occurrence, we assume that during the operation an application error may have taken place.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.
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: SLIP SLEEVE FOR THREADED HOLDING SLEEVE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9991067
• Report Number: 8030965-2020-03069
• Device Sequence Number: 3699676
• Product Code: LXH
• UDI-Device Identifier: 07611819964051
• UDI-Public: (01)07611819964051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2020

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: 03.614.036
• Device Lot Number: 8289568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 05/18/2020; 06/03/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 05/29/2020; 06/08/2020
• 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: HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; HOLD-SL; HOLD-SL; OUTERSLEEVE F/HOLDING SLEEVE NO. 03.614.; OUTERSLEEVE F/HOLDING SLEEVE NO. 03.614.