MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH QUARTER-TUBULAR PLATE WITH COLLAR 6 HOLES/47MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Catalog Number 242.06

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa. 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. (b)(4). 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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that the patient experienced post-op pain due to a broken plate. On (b)(6) 2019 the patient had an open reduction internal fixation (orif) procedure for a right second metacarpal fracture. During the procedure a 1/3 tubular plate and six (6) screws were implanted. Approximately, four (4) weeks after the procedure the patient experienced pain and it was discovered that the plate was broken. On (b)(6) 2020 the patient had an orif revision surgery and received a new plate and screws. The patient was reported as safe and was experiencing slow recovery. Concomitant devices reported: cortscr ø2. 7 l12 sst (part number 202. 012, lot unknown, quantity 2) screws (part number unknown, lot unknown, quantity 4). This report involves one (1) ¼-tub-pl 2. 7 6ho l50 sst. This is report 1 of 1 for (b)(4).

• Brand Name: QUARTER-TUBULAR PLATE WITH COLLAR 6 HOLES/47MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10385728
• MDR Text Key: 203744521
• Report Number: 8030965-2020-05833
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: CY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 242.06
• Device Lot Number: 2031198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2002
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/10/2020 Patient Sequence Number: 1