MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 2.0MM TI LCP(TM) PLATE 6 HOLES/45MM; PLATE, FIXATION, BONE

Model Number	447.346
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age or date of birth and weight not available for reporting.Date of device breakage is not known.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient who was implanted with a 2.0 mm titanium locking compression plate (6 holes) and four locking screws on (b)(6) 2017, was revised on (b)(6) 2018, after the plate was found to be broken.The previously implanted devices were removed and new hardware was placed.Concomitant devices reported: 2.0 mm titanium cortex screw, self tapping w/stardrive recess 10 mm (part 401.360, lot number unknown, quantity 3), 2.0 mm titanium cortex screw, self tapping w/stardrive recess 11 mm (part 401.361, lot number unknown, quantity 1), 2.0 mm titanium cortex screw, self tapping w/stardrive recess 12 mm (part 401.362, lot number unknown, quantity 1), 2.0 mm titanium cortex screw, self tapping w/stardrive recess 14 mm (part 401.364, lot number unknown, quantity 1), this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional 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.
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part # 447.346, synthes lot number: 9408794, manufacturing location: (b)(4), release to warehouse date: 10.Mar.2013: 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.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
A product investigation was performed.Please note this investigation is being done from the supplied photo.The complaint part belongs to the modular mini fragment lcp system and used for fixation of fractures of small bones (technique guide: (b)(4)).The photo shows a broken plate along the third combi hole from the side marked with the part/lot number.The balance of the device shows signs of being worn indicating the implant was inserted and explanted.Replication is not applicable due to not having the physical device to evaluate.Relevant drawings for the returned instrument were reviewed (both current and from the time of manufacture): top-level ((b)(4)).No design issues or discrepancies were identified.A dimensional inspection was not performed due to not having the physical device to evaluate and was able to be visually confirmed.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and in each instance no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.A root cause could not be determined as circumstances surrounding the complaint are unknown.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: 2.0MM TI LCP(TM) PLATE 6 HOLES/45MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7240943
• Report Number: 8030965-2018-50844
• Device Sequence Number: 10953610
• Product Code: HRS
• UDI-Device Identifier: 10886982223814
• UDI-Public: (01)10886982223814(10)9408794
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063049
• 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,Followup,Followup
• Report Date (Section B): 01/11/2018

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: 447.346
• Device Catalogue Number: 447.346
• Device Lot Number: 9408794
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/09/2018; 04/05/2018; 04/05/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 02/09/2018; 04/09/2018; 04/10/2018
• 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