MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM; BONE STAPLE

Model Number	SE-1515TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.Product investigation has not been completed; no conclusion could be drawn, as no product was received.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute 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.
Event or Problem Description
It was reported that the 2.65 mm drill guide broke off at the neck junction of the drill guide during a procedure.There was no surgical delay and no patient harm.Concomitant device(s) reported: speed titan compression implant (part #: se-1515ti, lot #: bse170019, qty: 1).This complaint involves 1 part.
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Event description and concomitant device updated.Dhr review was completed.Part number: se-1515ti bme, lot number: bse170019, manufacturing date or release to warehouse date: 7 feb 2017, place of manufacture: (b)(4), lot expiration date: 13 jan 2022.Dhr review: a review of the device history record revealed no complaint related anomalies.Review of the device history record revealed one non-conformance (ncmr).The ncmr was generated due to one (1) implant kit with a broken slider.Lot bse170019 was released as conforming as the nonconforming kit was scrapped.The nonconformance is not relevant to the complaint because the nonconforming component has no interaction with the drill guide.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.The review of the raw material device history record revealed two nonconformance's to be associated to raw material lot 1609129271.One ncmr was generated due to four (4) implants failing post-tumbling dimensional inspection.The other ncmr was generated due to one (1) implant showing scratches on one leg.Lot 1609129271 was released as conforming as all nonconforming parts were scrapped.The nonconformance is not relevant to the complaint because nor dimensional issues nor cosmetic appearance of the raw material would contribute to the drill guide breaking during surgery.This raw material lot met all dimensional and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.The review of the raw material device history record shows raw material lot 1610129301 was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This raw material lot met all dimensional and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.Corrected data: common name.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 the 2.65mm drill guide broke off at the neck junction while drilling during a procedure on (b)(6) 2017.The fragment was easily removed.There was no patient harm.The surgery was completed successfully with no delay.Concomitant device reported: speed drill kit (part dk-265-s, lot bmedk1604011, quantity 1).
Additional Manufacturer Narrative
Corrected data: udi number.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: SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7201716
• Report Number: 2939274-2018-50302
• Device Sequence Number: 16483098
• Product Code: JDR
• UDI-Device Identifier: 00810633021514
• UDI-Public: (01)00810633021514(10)BSE170019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2022
• Device Model Number: SE-1515TI
• Device Catalogue Number: SE-1515TI
• Device Lot Number: BSE170019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 01/10/2018; 02/12/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 02/08/2018; 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR