MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI VA-LCP OLECRANON PL 2H/RT/90MM-STER; PLATE, FIXATION, BONE

Catalog Number 04.107.202S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Part number: 04.107.202s; lot number: 48p8447; part manufacture date: 27-mar-2020; manufacturing location: (b)(4).Part expiration date: 01-mar-2030; nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of va-lcp olecr pl 2.7/3.5 r 2ho l90 tan product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Part number: 04.107m202sp; lot number: 45p4456; part manufacture date: 10-mar-2020; manufacturing location: (b)(4).Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of va-lcp olecr pl 2.7/3.5 r 2ho l90 tan product was processed through the normal manufacturing and inspection operations with no nonconformities noted.This lot was processed one time through an in-process rework.This rework is allowable as part of the normal manufacturing process.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional, and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 surgery for a proximal ulna.During the screw insertion, when the screw head achieved the plate, the metal residue which might have peeled off from the screw head, was generated around the screw head and the screw couldn¿t be locked into the plate properly.The surgeon tried to insert the screw again but couldn¿t and gave up inserting the screw.The surgery was completed with a 30 minute delay.The insertion angle was too heavy to lock, but the surgeon inserted the screw at a 15 degree angle.This report is for one (1) 2.7mm/3.5mm ti va-lcp olecranon pl 2h/rt/90mm-ster.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7MM/3.5MM TI VA-LCP OLECRANON PL 2H/RT/90MM-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10740662
• MDR Text Key: 213448327
• Report Number: 8030965-2020-08197
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.107.202S
• Device Lot Number: 48P8447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1