MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP PLATE 5 HOLES 72MM; PLATE, FIXATION, BONE

Model Number	223.551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as (b)(6) centimeters.Additional patient identifier: (b)(6).Date patient pain began is not known.Additional product codes: hwc, ktt.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.Dhr review for part # 223.551 lot # 7241154.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm lcp plate 5 holes 72mm 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 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.Release to warehouse date: 04 february 2013.Manufacturing site: (b)(6).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 a patient requested that all his hardware be removed due to pain.The original implant date was (b)(6) 2016 for a left radius and ulna fractures and a left femur fracture due to a motor vehicle accident.All the bones were healed and the hardware was removed fully intact.The surgery was successfully completed with no surgical delay.The patient was stable following surgery.This report is for one (1) 3.5mm lcp plate.This is report 3 of 11 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 5 HOLES 72MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6877467
• Report Number: 3003506883-2017-10206
• Device Sequence Number: 1408909
• Product Code: HRS
• UDI-Device Identifier: 10886982157898
• UDI-Public: (01)10886982157898(10)7241154
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 223.551
• Device Catalogue Number: 223.551
• Device Lot Number: 7241154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 91