MAUDE Adverse Event Report: SYNTHES TUTTLINGEN HOHMANN RETRACTOR/18MM WIDTH LONG NARROW TIP

Catalog Number 399.27

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot number t115083.Manufacturing location: synthes (b)(4).Date of manufacture: dec 15, 2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A review of inspection records and certifications, confirm that the, material, components and final product met inspection records, certification.All (b)(4) parts of the lot were checked 100% for ctq features and for function at the final inspection on dec 12, 2014.The subject device has been received and is currently in the evaluation process.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 during an unknown procedure on (b)(6) 2016 the surgeon was using a hohmann retractor to retract soft tissue when the tip broke off in the patient.The broken portion of the tip was recovered and another retractor was used to complete the procedure successfully.The surgery was delayed between 14 and 30 minutes due to the reported event.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

A product investigation was completed: this complaint is confirmed, the distal tips of the returned device is sheared off at the location where the tip transitions from flat to upward direction.The sheared off fragment for would be approximately 6mm long as measured reference to the product drawing.Unable to determine a definitive root cause.Most likely due to application of significant leverage/prying force which exceeded the material strength of the distal tip.A visual inspection under 5x magnification, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned retractor is an instrument commonly used in the hip preservation surgery set per the technique guide.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: HOHMANN RETRACTOR/18MM WIDTH LONG NARROW TIP
• Type of Device: RETRACTOR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5885449
• MDR Text Key: 52399892
• Report Number: 9680938-2016-10133
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.27
• Device Lot Number: T115083
• Other Device ID Number: (01)10886982202642(10)T115083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• 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