MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SERRATED CURETTE-7.5MM WIDTH STRAIGHT

Model Number SD389.881

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: flow: damage.Visual inspection: it was noticed that the device shaft was broken off at the distal end.Hence, the complaint can be confirmed for the reported condition.The broken pieces were received.Dimension inspection: a proper dimension can not be measured due to the tapered shaft and the post manufacturing damage.Investigation conclusion: no definitive root cause was able to be determined.However, the received condition is consisted with exceeding lateral forces potentially form off-axis use or incomplete attachment of the mating attachments.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part # sd389.881.Synthes lot # 6849420.Supplier lot # na.Release to warehouse date: feb 21, 2012.Manufactured by synthes brandywine.Nc-us1070825 was generated for shaft dim 22 specification 3.5 - 4.0 and finding was u/s 3.355 - 3.481.This non-conformance is not relevant to the complaint condition since rework and inspection, dim 22 was at specified distance.Qty 8 passed inspection.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of the product 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 Description

It was reported that on (b)(6) 2020, the patient underwent a revision l2-pelvis transforaminal lumbar interbody fusion (tlif).During the procedure, a straight serrated curette was broken while performing a discectomy.The l2 level was collapsed and highly ossified and while performing the discectomy at this level the curettes became stuck and were broken into 3 pieces while removing.An alternate non-serrated curette was used to finish, and all pieces were confirmed removed by fluoroscopy.The original implants were not synthes, the surgeon ran a second rod from ileum-l2 to reinforce the whole structure since it is not continuous.The procedure was completed as planned with no surgical delay.The patient's status is unknown.This is report 01 of 01 of (b)(4).

• Brand Name: SERRATED CURETTE-7.5MM WIDTH STRAIGHT
• Type of Device: CURETTE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9694117
• MDR Text Key: 191603309
• Report Number: 2939274-2020-00776
• Device Sequence Number: 1
• Product Code: HTF
• UDI-Device Identifier: 10705034708416
• UDI-Public: (01)10705034708416
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD389.881
• Device Catalogue Number: SD389.881
• Device Lot Number: 6849420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR