MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 4H/RT/81MM; PLATE, FIXATION, BONE

Model Number	02.112.010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Patient weight not available for reporting.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.(b)(4).Dhr review was completed.Part mfg date: 11 september 2008.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 3.5 mm lcp sup ant clavicle pl w/lat extn 4h/rt/81 mm was processed through the normal manufacturing and inspection operations with no nonconformance 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 one nonconformance material review record to be associated to raw material lot 5731244.The material review record was generated due to cosmetics in relation to minor pitting.Lot 5731244 was released as conforming as minor pitting will be removed during finishing and any cosmetically unacceptable material would be found at the 100% visual final inspection operation.The nonconformance is not relevant to the complaint because cosmetic appearance of raw material would not contribute to a new fracture outside of the existing clavicle plate.This raw material lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history record revealed one nonconforming report to be associated to raw material lot 5802778.The nonconforming report was generated due to a part being out of specification for feature w1.The nonconformance is not relevant to the complaint because the centering feature of the raw material forging would not contribute to a new fracture outside of the existing clavicle plate.This raw material lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this 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.
Event or Problem Description
It was reported that a hardware removal and revision was performed on (b)(6) 2017 due to a new fracture just outside the site of an existing clavicle plate.The original procedure, a clavicle fracture repair, was performed on an unknown date due to a mountain biking accident.Removed hardware included: one (1) plate and seven (7) screws, all intact.All devices were easily removed.No reported surgical delays, no fragments involved, no additional x-rays required.The patient was revised to: one (1) 2.7 mm locking compression (lcp) plate and an unknown quantity of screws.The original fracture site was noted to be fully healed.The procedure was completed successfully with the patient in stable condition.This report is for one (1) 3.5 mm lcp superior anterior clavicle plate with lateral extension.This is report 1 of 8 for (b)(4).

• Brand Name: 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 4H/RT/81MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 7041864
• Report Number: 3003506883-2017-10270
• Device Sequence Number: 13697447
• Product Code: HRS
• UDI-Device Identifier: 10886982032638
• UDI-Public: (01)10886982032638(10)5869254
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/26/2017

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: 02.112.010
• Device Catalogue Number: 02.112.010
• Device Lot Number: 5869254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention