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 Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.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-conformance's 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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on an unknown date in (b)(6) 2019 the patient underwent surgery for a distal humeral fracture using the 2.7mm/3.5mm variable angle lcp elbow system.It was not reported how the surgery was completed.On (b)(6) 2020, the removal surgery was performed.During the removal surgery, screw heads of the three (3) locking screws (lateral plate: 2 and medial plate: 1) stripped.The surgeon used an extraction instrument by removing the screw head and tried to remove the three locking screws after cutting the bone around the screws with a hollow reamer.As the screw head of one (1) locking screw implanted at a medial plate was stuck in the extraction instrument, the surgeon removed this locking screw while using the hollow reamer together.The other two (2) locking screws implanted at a lateral plate were also removed by using only the extraction instrument.All the locking screws were successfully removed.There were no broken parts left in the patient¿s body however, the bone defects occurred on the bone surface.There was a 120-minute surgical delay.This report is for one (1) 2.7mm/3.5mm ti va-lcp ext medl dhp 1h/lt/72mm-short-ster.This is report 5 of 6 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: 10489191
• MDR Text Key: 205641268
• Report Number: 8030965-2020-06599
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• 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: 08/11/2020
• 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
• Patient Age: 17 YR