MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM BROAD LCP® PLATE 16 HOLES/296MM; PLATE,FIXATION,BONE

Model Number	223.661
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient id (b)(6) patient date of birth/age, sex and weight were not provided for reporting.Additional device product codes: hwc, ktt.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Patient code (b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.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 (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, patient was implanted with 4.5 / 5.0 locking compression plate, five (5) locking screws and three (3) cortical screws.Post-operative, on an unknown date, patient experienced a break of a 4.5 / 5.0 locking compression plate.Patient underwent removal surgery on (b)(6) 2018.Concomitant devices reported: 5.0mm x 30mm locking screw (part# unknown, lot# unknown, quantity 1), 5.0mm x 32mm locking screw (part# unknown, lot# unknown, quantity 1), 5.0mm x 34mm locking screw (part# unknown, lot# unknown, quantity 1), 5.0mm x 38mm locking screw (part# unknown, lot# unknown, quantity 1), 5.0mm x 40mm locking screw (part# unknown, lot# unknown, quantity 1), 4.5mm x 30mm cortical screw (part# unknown, lot# unknown, quantity 1), 4.5mm x 38mm cortical screw (part# unknown, lot# unknown, quantity 1), 4.5mm x 50mm cortical screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) 4.5mm broad lcp® plate 16 holes/296mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A device history record (dhr) review was performed for part no.: 226.661, lot no.: l081199, manufacturing location: (b)(4), release to warehouse date: 02.Aug.2016: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM BROAD LCP® PLATE 16 HOLES/296MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7270848
• Report Number: 8030965-2018-51113
• Device Sequence Number: 16719586
• Product Code: HRS
• UDI-Device Identifier: 10886982158109
• UDI-Public: (01)10886982158109(10)L081199
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: 223.661
• Device Catalogue Number: 226.661
• Device Lot Number: L081199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention