MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; RETRACTOR

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown synframe retractor blade/unknown lot.Part and lot number are unknown; udi number is unknown.It is unknown which retractor blade was used; potential part/lot numbers provided: part 03.609.008, lot l785787; part 03.609.010, lot l806792; part 03.609.012, lot l827956; part 03.609.014, lot l715402; part 03.609.016, lot l715403; part 03.609.018, lot l724144; part 03.609.020, lot l796569; part 03.609.028, lot l806803; part 03.609.030, lot l715405; part 03.609.032, lot l375241 or l806791; part 03.609.034, lot l816781; part 03.609.036, lot l816786; part 03.609.038, lot l695554; part 03.609.040, lot l785793 or l828080.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

It was reported that on (b)(6) 2019, during a case, there was a difficulty with the synframe retractor blades holding the toe.The patient was heavy, and they tightened both the toe point and the blade/frame attachment point but the blades kept loosening the toe.They had to swap out the retractor for a non-synthes retractor, causing a procedural delay, and ended up using a non-synthes implant as a result.The procedure was completed successfully.There was no patient harm.This report is for an unknown synframe retractor blade.This is report 1 of 1 for (b)(4).

• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8599821
• MDR Text Key: 145113029
• Report Number: 2939274-2019-57952
• Device Sequence Number: 1
• Product Code: GAD
• 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: Physician
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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