MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LCP DRILL SLEEVE 2.7 F/DRILL BIT Ø2 F/LC; GUIDE

Catalog Number	03.108.036
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported (b)(6) 2019 that a variant osteotomy of the proximal femur of a (b)(6) year-old patient was performed, the surgeon decided to place a 2.7 ° plate 2.7 mm system and fix the plate with 2.7mm locking screws.After placing the proximal screws as instructed by the technique, the surgeon proceed to perform the diaphyseal fixation of his preference with locking screws.The first hole is drilled and the screw is placed.When placing the lcp drill guide in the next hole in the plate, this guide fell¿s down.Since no other guide is available, the surgeon necessarily decides to place a cortex screw, which was not adequate for the technique that the surgeon handles.Procedure is terminated without any other complications.But the surgeon shows a lot of disagreement; since the team does not have another guide, and he says that they can present this type of incidents which could be solved in an appropriate way if the system had another guide as they have the system of 3.5 and 4.5 of the lcp pediatric.At the time of the incident, i try to handle the situation and provide a solution with a team on the stock of the distal radius that is in the institution, and i order this equipment, with the bad luck that the lcp drill guide fits perfectly on the plate, but it is a guide for 1.8mm drill bit and it was not possible to pass it for 2.7mm locking screws.Concomitant devices reported: unknown locking screws (part# unknown, lot# unknown, quantity# unknown) unknown plates (part# unknown, lot# unknown, quantity# 1) unknown screws: cortex (part# unknown, lot# unknown, quantity# unknown).This is 1 of 1 for report (b)(4).

• Brand Name: LCP DRILL SLEEVE 2.7 F/DRILL BIT Ø2 F/LC
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9297183
• Report Number: 8030965-2019-70112
• Device Sequence Number: 11390361
• Product Code: FZX
• UDI-Device Identifier: 07611819412828
• UDI-Public: (01)07611819412828
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 10/22/2019

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 Catalogue Number: 03.108.036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR