MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE; PLATE,FIXATION,BONE

Catalog Number 04.211.201S

Device Problems Break (1069); Device Operational Issue (2914)

Patient Problem Not Applicable (3189)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age not provided for reporting.Additional product code: hwc.Not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: the manufacturing documents were reviewed and no complaint related issues were found.Product was not returned, therefore no further investigation is possible.Based on the information available, 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.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 on an event in (b)(6) as follows: on (b)(6) 2018, this implant was used in the surgery for hallux valgus(left).X-pl-2.4/2.7 va lock xs 23.5*15 tan.During the surgery, two surgeons were involved in bending of this plate.One surgeon held the plate while the other surgeon bent it.One screw hole of the plate broke while bending, they tried to use another size of the plate, but it was too big to be implanted.The broken plate was used by inserting a cortical screw and the surgical incision was closed.Surgery was completed with a 10-minute delay.There was no adverse consequence to the patient.Post-operative condition of the patient and the fixation of the broken plate are both good.This complaint involves 1 part.Plate other size (part# unknown / lot# unknown / quantity 1), cortical screw (part# unknown / lot# unknown / quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device: part: 04.211.201s, lot: l295355, manufacturing site: (b)(4), release to warehouse date: 22.Feb.2017, expiry date: 01.Feb.2027.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7289001
• MDR Text Key: 100686377
• Report Number: 8030965-2018-51307
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819445123
• UDI-Public: (01)07611819445123(17)270201(10)L299535
• Combination Product (y/n): N
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.201S
• Device Lot Number: L295355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 03/22/2018
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 81