MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 7H HD/3H SHAFT/RT; PLATE, FIXATION, BONE

Model Number	04.111.730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when device broke.Lot number is unknown.It is unknown when device was implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on an unknown date, the surgeon reported occasional breakages of the 2-column volar distal radius plate.The surgeon had one case in (b)(6) 2017.Subsequent to implantation, the plate broke and the patient had revision surgery, then went on to heal.There was no reported delay in surgery.The surgeon believes the plate breaks through the k-wire holes on the two arms of the plate.The surgeon feels these holes are not necessary and provide a weak point in the plate.The surgeon also feels that if there is a delayed union following corrective osteotomy then the plate may break.This report is for a 2.4mm titanium (ti) va-lcp 2-clmn vlr dst radius pl 7h hd/3h shaft/rt.This is report 1 of 1 for (b)(4).

• Brand Name: 2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 7H HD/3H SHAFT/RT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7694944
• Report Number: 8030965-2018-55121
• Device Sequence Number: 13834980
• Product Code: HRS
• UDI-Device Identifier: 10886982102126
• UDI-Public: (01)10886982102126
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.111.730
• Device Catalogue Number: 04.111.730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention