MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 13H/RIGHT/203MM; PLATE,FIXATION,BONE

Model Number	02.112.156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional product code: hwc.Implant date: the original surgery took place approximately 5 months ago.Device is not expected to be returned for manufacturer review/investigation.Additional reporters phone number: (b)(6).(b)(4).A device history record (dhr) review was performed: date of manufacture (release to warehouse date): 22 december 2014.Place of manufacture: synthes usa- (b)(4).Expiration date: 30 november 2024.Lot 7855050, part number 02.112.156s, work order (b)(4).A review of the device history record (dhr) for lot 7855050, part number 02.112.156s (description: 2.7mm/ 3.5mm lcp lat distal fibula plate 13h/ rt/ 203mm-sterile), work order (b)(4) revealed zero manufacturing/complaint related anomalies.The documentation reviewed shows that lot 7855050 was processed through normal manufacturing and inspection operations without any confirmed non-conformance's.The dhr evaluation confirms that the lot met all documentation, dimensional, and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.Synthes lot 7831717, part number 49005 (b)(4).A review of the device history record (dhr) for raw material synthes lot 7831717, part number 49005 (description: (b)(4) forged raw material) revealed zero manufacturing/complaint related anomalies.The dhr evaluation confirms that the lot met all documentation, dimensional, and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 fibula hardware removal was performed on (b)(6) 2017 for the removal of the 2.7mm/3.5mm lcp lateral distal fibula plate 13h/right/203mm device due to malunion and draining (possible infection).All of the hardware was removed.The original surgery took place approximately 5 months ago.This complaint has 4 device.This report is 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Other udi: (b)(4).Device 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: 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 13H/RIGHT/203MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6894443
• Report Number: 3003506883-2017-10216
• Device Sequence Number: 19010686
• Product Code: HRS
• UDI-Device Identifier: 10886982034250
• UDI-Public: (01)10886982034250(10)7855050
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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: 02.112.156
• Device Catalogue Number: 02.112.156S
• Device Lot Number: 7855050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 10/27/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 98