MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PROTECT SLEEVE 16/11 F/PFNA BLADE; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 356.818

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 Description

It was reported that on (b)(6) 2019, during a proximal femoral nail antirotation case, an unknown insertion handle got stuck in the protection sleeve and would not release.The protection sleeve and buttress/compression nut were damage to release the device, which now will not separate.A pfna blade perforated was damaged.It was badly scratched from the removal process after it got stuck and discarded being replaced with the same size blade.The procedure was completed successfully with a surgical delay of 15 minutes.The patient consequence was unknown.This complaint involves three (3) devices.This report is for one (1) protect sleeve 16/11 f/pfna blade.This report is 2 of 3 for (b)(4).

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.Initial reporter address: (b)(6).Device history lot: part: 356.818.Lot: 8948278.Manufacturing site: bettlach.Release to warehouse date: 16.May.2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: investigation site: cq zuchwil.Selected flow(s): 2.Device interaction/functional and 3.Damaged: visual | examples: deformed/bent/cracked.Visual inspection: upon visual/initial inspection of the complaint and received back instruments, it can be seen that the both parts (sleeve and buttress) have dents and scratches all over the parts, furthermore we have received them in a completely blocked condition, this thus confirming the complaint description.The parts got blocked to each other based on the damage (dents) on the sleeve.Functional test: during investigation some functional test were performed.The sleeve has failed the function test based on the already described damage (dents), furthermore the buttress has passed the function test as we are able to screw the buttress up and down the undamaged section on the sleeve.In addition we have done function test with the sleeve and a insertion handle (356.823 / 2156675), the function test has passed.Document/specification review: drawings and revisions are in accordance to dhr of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Material or hardness review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no material or hardness review is needed.Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary worn or damaged instruments to replace and/or to operate according to the technique guide.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.

• Brand Name: PROTECT SLEEVE 16/11 F/PFNA BLADE
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8461919
• MDR Text Key: 140302210
• Report Number: 8030965-2019-62325
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819291300
• UDI-Public: (01)07611819291300
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 356.818
• Device Lot Number: 8948278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: 03/03/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 05/08/2019
• Patient Sequence Number: 1