MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP SUPERIOR CLAVICLE PLATE/7H/RIGHT/100MM-STERILE; PLATE, FIXATION, BONE

Catalog Number 04.112.082S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Packaged, sterilized and released by: (b)(4), release to warehouse date: 14-aug-2019, expiration date: 01-jul-2029, part number: 04.112.090s, 305mm ti lcp sup clav plate w/lat extn/6h/rt/105mm-sterile, lot number: 13l2475 (sterile), lot quantity: (b)(4).Note: plate was manufactured by (b)(4); lot number 12l3809.Parts were packaged, sterilized and released by (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn (b)(4) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual, sterility 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 osteosynthesis surgery.During the surgery the plate didn¿t fit to the patient¿s clavicle after a few screws were inserted into the plate holes.The plate was removed once and bent.The plate was bent a few times and eventually broke.Another plate was used to complete the procedure successfully without any surgical delay.Concomitant device: unknown screw (part#: unknown, lot#: unknown, quantity: unknown).This report is for one (1) 3.5mm ti lcp superior clavicle plate/7h/right/100mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM TI LCP SUPERIOR CLAVICLE PLATE/7H/RIGHT/100MM-STERILE
• 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: 10754993
• MDR Text Key: 213695540
• Report Number: 8030965-2020-08327
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073460
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.112.082S
• Device Lot Number: 13L2475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA