MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DISTRACTOR PINS-STERILE 14MM LENGTH; TAP, BONE

Model Number	U44-640-14-02S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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 on (b)(6) 2020, during an anterior cervical fusion, a distractor pin broke off in c5.Fragments were generated and the fragment remained in the patient's c5 vertebral body.It is unknown if there was a surgical delay.The procedure was completed successfully.Patient status was unknown.This report is for one (1) distractor pins-sterile 14mm length this is report 1 of 1 for (b)(4).

• Brand Name: DISTRACTOR PINS-STERILE 14MM LENGTH
• Common Device Name: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9664869
• Report Number: 2939274-2020-00628
• Device Sequence Number: 418588
• Product Code: HWX
• UDI-Device Identifier: 20705034711031
• UDI-Public: (01)20705034711031
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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: U44-640-14-02S
• Device Catalogue Number: U44-640-14-02S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR