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

Model Number	04.111.731
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event reported as 2018.Exact date of device breakage is not known.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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient was implanted with the variable angle locking compression plate (va lcp) two-column volar distal radius plate on (b)(6) 2018.On unknown date it was determined the plate was broken and patient had developed non-optimal fixation.Patient was returned to surgery on (b)(6) 2018 where the broken plate was removed.It is not known what additional hardware was implanted.This report is for one (1) va lcp two-column volar distal radius plate.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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
Concomitant devices: screw (part: unknown, lot: unknown, quantity: unknown).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Dhr review was completed.Part:04.111.731 , lot:l893362 , manufacturing site: mezzovico , release to warehouse date: 18.May 2018.The device history record shows this lot of 21pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate 60062495 with the lot no.L888545 was reviewed and the used material was according specification for implants for surgery.This implant was manufactured from 60010283 lot l829908 from hempel metals and more.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition customer quality conducted an investigation of the returned device.A broken va-lcp two-column distal radius plate was returned for investigation.Implant was forwarded to the manufacturing site and was checked for conformance to the specifications.The review of the device history record revealed that this implant was manufactured in may 2018 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.As per selected investigation flow, a visual inspection has been performed and it confirmed that the received condition agrees with the complaint condition but no visual defects manufacturing related have been identified on returned item.The dimensional re-inspection, the raw material certificate review and the document/specification review didn¿t identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 7H HD/3H SHAFT/LT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7950182
• Report Number: 8030965-2018-57144
• Device Sequence Number: 2338277
• Product Code: HRS
• UDI-Device Identifier: 10886982102140
• UDI-Public: (01)10886982102140
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2018

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: 04.111.731
• Device Catalogue Number: 04.111.731
• Device Lot Number: L893362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/16/2018; 11/08/2018; 11/12/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/01/2018; 11/08/2018; 11/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR