MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR FRAME MEDIAL/LATERAL

Model Number 03.615.002

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

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) 2019 during surgery the retractor frame medial lateral and retractor frame cranial caudal distractors of the minimally invasive surgical support system have worn out and slipping during surgery.They no longer hold the position tightly they are intended to.Surgical delay is unknown.The procedure was successfully completed without delay.Patient status is unknown.This is report 3 for 3 (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the retractor frame medial/lateral (part # 03.615.002) was received at us cq.The received device consisted of a retractor fixed half from lot # t103755 and a retractor floating half from lot # t103766.Both halves were correctly etched with their parent part number (03.615.002) and their respective lot #¿s.This device is distributed as a completed assembly thus components were utilized from two separate retractors to form the received retractor.Based on this information, it can be determined that the retractor from lot # t103755 was missing its floating half, while the retractor from lot # t103766 was missing its fixed half.The device had minor scratches along its body.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.Functional test: functional testing showed that the device functioned as intended.When in the 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 counter clockwise to widen the device¿s position.This motion is allowed per the design of the device.The device not compress when in its locked position.The only time the device compresses is if the device is unlocked.Although there are signs of wear on the tooth wheel, the device is holding 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.The complaint is not confirmed.The complaint cannot be replicated with the returned device; the device functioned appropriately.Dimensional inspection: dimensional inspection was not performed since the reported condition of the functional issue is not confirmed.Document/specification review: based on the different lot numbers of the assembly, both the manufactured to and current drawing revisions were reviewed.Based on the noted changes, there were no design changes that would impact the compatibility of components from different lots.Manufacturing record evaluation: the received retractor frame medial/lateral (part # 03.615.002 lot # t103755) was manufactured at the tuttlingen site on 16-jul-2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the overall complaint for the received retractor frame medial/lateral (part # 03.615.002 lot # t103755) is 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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 03.615.002; lot number: t103755; manufacturing site: tuttlingen; release to warehouse date: 16.Jul.2014.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: RETRACTOR FRAME MEDIAL/LATERAL
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9035272
• MDR Text Key: 158194702
• Report Number: 2939274-2019-60541
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034715223
• UDI-Public: (01)10705034715223
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.615.002
• Device Catalogue Number: 03.615.002
• Device Lot Number: T103755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1