MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR FRAME CRANIAL/CAUDAL

Model Number 03.615.100

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: investigation flow: functional/device interaction.Visual inspection: the retractor frame medial/lateral (p/n: 03.615.002, lot #: t125203) was returned and received at us cq.Upon visual inspection, both halves were correctly etched with their parent part number (03.615.002) and their respective lot #¿s.There were scratches on the device but has no impact on the functionality of the device.The teeth on the tooth wheel of the floating half and the teeth on the rack of the fixed half were slightly worn.No other defects were identified with the returned components of the device.Functional test: the functional test was performed on the returned device.During the functional test, when in a locked position, the retractor floating half does not move freely and holds its position as designed.While in the locked position the sliding half only moves if the pinion shaft assembly is rotated counterclockwise to widen the device¿s position.This motion is allowed per the design of the device.The only time the device compresses is if the device is unlocked.Although there were signs of wear on the tooth wheel, the device is holding a position adequately and is not loose.The blade holder on both the right- and left-hand side also function as intended.They have the intended motion when the saddle is either depressed or released.Can the complaint be replicated with the returned device(s)? no.Complaint confirmed? no.Investigation conclusion: the overall complaint about the received retractor frame medial/lateral (part # 03.615.002 lot # t125203) was not confirmed because the device holds its position and functions as designed.The observed cosmetic issues are consistent with normal wear.Although no definitive root-cause can be determined for the missing floating half, it is possible that the component was misplaced during a sterilization cycle or during use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 number: 03.615.100.Lot number: t125203.Manufacturing site: tuttlingen.Release to warehouse date: may 12, 2016.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.(b)(4).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) 2002, the surgeon was performing a l3-l5 micro disc on a patient with the synthes insight blade retractor.The surgeon could not expand or toe out either of the retractor frames, tried both the retractor frame medial/lateral and retractor frame cranial/caudal.The surgeon also demonstrated how on 1 of the 2 arms that ratchet that holds the arm articulated must be worn out.The arm on both of these retractor frames will not hold.Surgical delay was about 4 minutes while the surgeon adjusted the retractor to make it work.The procedure was successfully completed.No harm to the patient.This is report 02 of 02 of (b)(4).

• Brand Name: RETRACTOR FRAME CRANIAL/CAUDAL
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; SZ 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9741269
• MDR Text Key: 191294018
• Report Number: 2939274-2020-00996
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034715360
• UDI-Public: (01)10705034715360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.615.100
• Device Catalogue Number: 03.615.100
• Device Lot Number: T125203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• 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: 76 YR