MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 4.5MM LCP® PROXIMAL FEMUR PLATE 8 HOLES/247MM-RIGHT; PLATE, FIXATION, BONE

Model Number	242.808
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes for this report include hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Therapy date of concomitant device is (b)(6) 2017.A device history record review was requested.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 the patient was implanted with a 4.5 mm lcp proximal femur plate 8 holes/247mm-right.The control surgery was going well, managed to gain length that was initially lost, was progressing well, without pain.However, on (b)(6) 2018, the implant broke.As per the surgeon's report, the patient followed all the postoperative recommendations and apparently the patient did not exercise or stress the material, nor suffered any fall.After (b)(6) 2018, the patient underwent a new procedure.The broken plate was removed and replaced with xpert lfn ø12 r cann l360 tan part number: 04.003.552 / lot: 9796927.Concomitant device(s): unknown screws (part #: unknown, lot #: unknown, qty: unknown).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device returned to manufacturer.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Additional information regarding concomitant screws: during the investigation on the reported plate the concomitant screws were identified as follows; 5.0mm locking screws: (per device etching) part 212.212 | lot 9817554.Part 212.211 | lot l328840.Part 212.212 | lot 9817554.Part 212.211 | lot l328840.Part 212.212 | lot 9817554.5.0mm cannulated screws (per drawing 02_205_025 rev.F) --part 02.205.075 | lot unknown [identified based on visual conformance to the features on print 02_205_025 rev.F, a measured length of 75.52mm (within the specification of 75mm +0.8/-0 per drawing 02_205_025 rev.F), and a measured major thread diameter of 4.85mm (within the specification of 5.05mm max per drawing 02_205_025 rev.F).] 7.3mm cannulated screw (per drawing 02_207_020 rev.H and es0116 rev.4) --part 02.207.080 | lot unknown [identified based on visual conformance to the features on print 02_207_020 rev.H, a measured length of 80.49mm (within the specification of 80mm +0.8/-0 per drawing 02_207_020 rev.H), and a measured major thread diameter of 7.23mm (within the specification of 7.3mm max per drawing es0116 rev.4).] --part 02.207.090 | lot unknown [identified based on visual conformance to the features on print 02_207_020 rev.H, a measured length of 90.45mm (within the specification of 90mm +0.8/-0 per drawing 02_207_020 rev.H), and a measured major thread diameter of 7.22mm (within the specification of 7.3mm max per drawing es0116 rev.4).] (calipers: ca102p) a device history record (dhr) review was performed for part number: 242.808 , lot number: h026614 , part mfg date: (b)(6) 2016 , part exp.Date: n/a (for sterile product) , manufacturing location: elmira, new york: no non-conformance reports (ncrs) were generated during production.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm lcp proximal femur plates was processed through the normal manufacturing and inspection operations with no non-conformance noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A product investigation was performed.The plate was received with a roughly transverse break through the third most proximal locking hole.The balance of the device shows surface scratching and thread wear consistent with implant and subsequent explant approximately 5 month later and which would not impact the functionality.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.Drawing review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.--lcp proximal femur plate, right: 242_802 rev.F.Dimensional inspection of the fractured threaded hole could not be completed due the break and observed damage.The thickness of the plate was inspected on each side of the fracture and found to measure 6.40/6.43mm (calipers: ca102p).This is within the specification of 6.5mm +0.7/-0.2 per drawing 242_802 rev.F cross sectional view l-l.The width of the plate was inspected on each side of the fracture and found to measure 18.23/18.24 (calipers ca102p).This is within the specification of 18mm +0.4/-0.15 per drawing 242_802 rev.F cross sectional view l-l.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root cause was able to be determined as circumstances surrounding the event and over the implant duration are unknown.Risk assessment review: the design and clinical risk management (dcrm) document was reviewed in action a-643717 and found to adequately address the complaint condition.Conclusion: the complaint condition is confirmed.A device history record (dhr) review, device inspection, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.This device lot and raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition and no product design issues or discrepancies were observed that may have contributed to the complaint condition.No new malfunctions were observed during the course of this investigation and the risk assessment was found to adequately address the complaint condition.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: 4.5MM LCP® PROXIMAL FEMUR PLATE 8 HOLES/247MM-RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7241610
• Report Number: 8030965-2018-50861
• Device Sequence Number: 16403017
• Product Code: HRS
• UDI-Device Identifier: 10886982168863
• UDI-Public: (01)10886982168863(10)H026614
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030858
• 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
• Report Date (Section B): 01/15/2018

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: 242.808
• Device Catalogue Number: 242.808
• Device Lot Number: H026614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/09/2018; 04/06/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/06/2018; 04/12/2018
• 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
• Patient Age: 66 YR
• Patient Weight: 70