MAUDE Adverse Event Report: DEPUY SPINE INC DISTRACTOR, 5.50MM; EXTRACTOR

Model Number 277050110

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: flow: damage.Visual inspection: visual inspection performed at customer quality (cq) identified the upper church spring broke just below when the spring starts to taper off.The broken piece was not returned.No other issues were identified.A device failure was identified.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage and device geometry.Document/specification review.The following drawing(s) was reviewed; based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot.A review of the receiving inspection (ri) for the distractor, 5.50mm was conducted identifying that lot number 0804k was released in a single batch.¿ batch1: lot qty of 25 units were released on 2004 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was underwent an unknown procedure performed on (b)(6) 2020.After postoperative cleansing of the distractor, it was discovered that the spring had come off.It was not used during the procedure.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: DISTRACTOR, 5.50MM
• Type of Device: EXTRACTOR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10097395
• MDR Text Key: 202031335
• Report Number: 1526439-2020-01089
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10705034196923
• UDI-Public: (01)10705034196923
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2020

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
• Device Operator: Health Professional
• Device Model Number: 277050110
• Device Catalogue Number: 277050110
• Device Lot Number: 0804K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 05/28/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1