MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/RT/69MM; PLATE,FIXATION,BONE

Model Number	02.112.006
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age or date of birth, gender, and weight not available for reporting.Date of device breakage is not known.Date of implant reported as (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date reported as (b)(6) 2017.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been 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
It was reported that a clavicle plate and screws were implanted on a patient on an unknown date in (b)(6) 2017.The patient was noncompliant post-operatively causing device failure.A plate hardware removal and revision was performed on (b)(6) 2017 due to patient non-compliance.A plate and screws were revised with new plates and screws.All the explanted devices were all intact with no allegations against them.There was no surgical time delay and no patient harm reported.The procedure was successful.Concomitant devices reported: screw (part number unknown, lot number unknown, quantity unknown) this report is for one (1) 3.5 mm lcp superior anterior clavicle plate with lateral extension-3 hole-right-69 mm.This is report 1 of 2 for com-(b)(4).
Additional Manufacturer Narrative
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 sup ant clavicle plate w/lat extn 3h/rt/69mm was processed through the normal manufacturing and inspection operations with one nonconformance noted.The noted nonconformance was ncr (b)(4).The ncr was related to cosmetics and all 24 parts were successfully reworked per synthes rework instructions.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 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.Part mfg date: 04 february 2011.Part exp.Date: n/a (for sterile part numbers).Manufacturing location: (b)(4).Adverse event only, no product problem.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
Concomitant devices removed.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 clavicle plate and screws were implanted on a patient on an unknown date in (b)(6) 2017.The patient was noncompliant post-operatively causing device failure.A plate hardware removal and revision was performed on (b)(6) 2017 due to patient non-compliance.A plate and screws were revised with new plates and screws.All the explanted devices were all intact with no allegations against them.There was no surgical time delay and no patient harm reported.The procedure was successful.This report is for one (1) 3.5mm lcp superior anterior clavicle plate with lateral extension-3 hole-right-69mm this is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/RT/69MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6898049
• Report Number: 3003506883-2017-10217
• Device Sequence Number: 898759
• Product Code: HRS
• UDI-Device Identifier: 10886982032553
• UDI-Public: (01)10886982032553(10)6581579
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111540
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2017

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: 02.112.006
• Device Catalogue Number: 02.112.006
• Device Lot Number: 6581579
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/27/2017; 09/29/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 09/28/2017; 10/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention