MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 1H/LT/72MM-SHORT-STER; PLATE,FIXATION,BONE

Catalog Number 04.117.701S

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Part: 04.117.701s, lot: 5l45838, manufacturing site: (b)(4), release to warehouse date: 09.Aug.2019, expiry date: 01.Jul.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent an open reduction internal fixation surgery for a left distal femur transcondylar fracture.After the screw was inserted it was discovered by x-ray that the locking screw was too long.The surgeon tried to remove the screw but was unable because the thread of screw head or the plate¿s hole was stripped.The surgeon removed all of other screws and removed the plate with the screw connected.The surgery was completed with another plate with a thirty (30) minute delay.Concomitant devices: unknown screws (part # unknown, lot # unknown, quantity unknown), unknown drill (part # unknown, lot # unknown, quantity 1), unknown screwdriver shaft (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 2.7mm/3.5mm ti va-lcp ext medl dhp 1h/lt/72mm-short-ster.This is report 2 of 2 for (b)(4).

• Brand Name: 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 1H/LT/72MM-SHORT-STER
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9987496
• MDR Text Key: 191402404
• Report Number: 8030965-2020-03041
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.117.701S
• Device Lot Number: 5L45838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1