MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HOLDING SLEEVE; GUIDE

Model Number	389.814
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
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 prior to a case on an unknown date, the scrub nurse was trying to assemble the anterior tension band (atb) driver.The inner shaft was stuck inside the self-retaining sleeve.A similar product was used instead.There was no patient consequence.This report is for a holding sleeve.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.H6: the instrument has been assessed and the condition in the event description was not able to be replicated.The screwdriver hex 3.5 (389.829) moves freely within the holding sleeve (389.814).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: part 389.814, lot 6440299: packaged and released by: monument.Release to warehouse date: december 02, 2010.Purchased finished goods traveler met all inspection acceptance criteria.Certificate of compliance was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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: HOLDING SLEEVE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9582908
• Report Number: 8030965-2020-00315
• Device Sequence Number: 18914193
• Product Code: FZX
• UDI-Device Identifier: 10705034776804
• UDI-Public: (01)10705034776804
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2019

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 Model Number: 389.814
• Device Catalogue Number: 389.814
• Device Lot Number: 6440299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 02/17/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/14/2020; 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1