MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM LCP® STRAIGHT WRIST PLATE 170MM; PLATE, FIXATION, BONE

Model Number	SD242.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height is reported as (b)(6).Date of postoperative plate breakage is unknown.Implanted 3 months prior to revision surgery.Therapy date is 3 months prior to revision surgery.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.
Event or Problem Description
It was reported that there was an unknown procedure that was performed three months ago where a patient was implanted with a 2.4mm locking compression plate (lcp) straight wrist plate and 8 screws (combination of 2.4 cortical and 2.7 cortical screws).Postoperatively, the patient complained of pain.An x-ray was taken on an unknown date and it was discovered that the plate had broken.Revision surgery was performed on (b)(6) 2017, where the broken plate and eight (8) intact screws were removed.The patient was not revised with new implants.There was no surgical delay and procedure was completed successfully.The patient outcome was as expected.Concomitant devices reported: 2.4mm cortical screws (part#: unknown, lot#: unknown, quantity unknown), 2.7mm cortical screws (part#: unknown, lot#: unknown, quantity unknown).This report is for one (1) 2.4mm lcp straight wrist plate 170mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part number: sd242.003 lot number: h259229 part manufacture date: 13-jan-2017 manufacturing location: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.4mm lcp straight wrist plate 170mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance 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.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A product development investigation was performed for the subject device: it was reported that three months after implantation a 2.4mm lcp straight wrist plate (sd242.003) was found to be broken after the patient experienced pain.The returned device was examined and the complaint condition was able to be confirmed as the plate was found to be broken at the center combi-hole.The complaint was unable to be replicated due to post-manufacturing damage.No definitive root cause was able to be determined with the provided information.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level (sd242_003).The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is applicable due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.It was reported that three months after implantation a 2.4mm lcp straight wrist plate (sd242.003) was found to be broken after the patient experienced pain.The returned device was examined and the complaint condition was able to be confirmed as the plate was found to be broken at the center combi-hole.The complaint was unable to be replicated due to post-manufacturing damage.No definitive root cause was able to be determined with the provided information.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level (sd242_003).The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is applicable due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the 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.

• Brand Name: 2.4MM LCP® STRAIGHT WRIST PLATE 170MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7080025
• Report Number: 2939274-2017-50135
• Device Sequence Number: 10988004
• Product Code: HRS
• UDI-Device Identifier: 10886982003638
• UDI-Public: (01)10886982003638(10)H259229
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K040588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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: SD242.003
• Device Catalogue Number: SD242.003
• Device Lot Number: H259229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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 Weight: 50