MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 11X10X10MM; BONE STAPLE

Model Number	SE-1110
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Implant and explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Part number: se-1110.Bme lot number: bmese160282.Manufacturing date or release to warehouse date: 26 august 2016.Place of manufacture: biomedical enterprises, (b)(4).Lot expiration date: 5 august 2021.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11mm speed staples 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.The review of the raw material device history record revealed three nonconformance (ncmr # (b)(4)) to be associated to raw material lot 1512120169.Ncmr (b)(4) was generated due to forty-six (46) implants failing dimensional post-edm inspection.Ncmr (b)(4) was generated due to a slug mixed in with the implants.Ncmr (b)(4) was generated due to six (6) implants presenting oxide stains.These nonconformance are not relevant to the complaint because this complaint is regarding a third-party device interfering during placement of a staple.Lot 1512120169 was released as conforming as all the nonconforming parts were scrapped or reworked to specification.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.Ncmr (b)(4) are not relevant to the complaint because this complaint is regarding a third-party device interfering during placement of a staple.Product was not returned.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.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 during a mtp fusion on (b)(6) 2017, when inserting the staple, one of the legs did not seat completely due to a previously implanted competitor¿s screw.Subsequently, the surgeon took the staple out and went to re-load it onto the handle, and the handle came apart (which it is supposed to do).There was a reported surgical delay of five minutes due to the surgeon re-inserting the implant without the handle.This could have been caused by a drilling error ¿ the previously inserted screw caused a limited area for drilling.The procedure was completed successfully with the patient in stable condition.This is report 1 of 1 for (b)(4).

• Brand Name: SPEED COMPRESSION IMPLANT KIT 11X10X10MM
• 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: 7076584
• Report Number: 2939274-2017-50123
• Device Sequence Number: 939005
• Product Code: JDR
• UDI-Device Identifier: 00810633020128
• UDI-Public: (01)00810633020128(17)210805(10)BMESE160282
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 11/01/2017

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: 08/05/2021
• Device Model Number: SE-1110
• Device Catalogue Number: SE-1110
• Device Lot Number: BMESE160282
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR