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 Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Date returned to manufacturer (b)(4).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: lot: t115083 part: 399.27, manufacturing date: 15-dec-2014, review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.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 12-dec-2014.No ncrs were generated during production.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 the tips of two hohmann retractors broke during a procedure to retract tissue on (b)(6) 2016.One tip could not be retrieved and was lost in the patient.It is unknown which of the two broken retractors tip remains in the patient.It is unknown how long the device has been in use by the hospital facility.A third retractor was readily available to successfully complete the procedure.There was no surgical time delay reported.This complaint involves 2 devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: product investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned retractors are instruments commonly used in the hip preservation surgery set per technique guide.This complaint is confirmed, the distal tips of the two returned devices are sheared off at the same general location where the tip transitions from flat to upward direction.The sheared off fragments for both devices (which were not returned) would be approximately 5mm long as measured with calipers (b)(4) with reference to product drawing.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.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 12-dec-2014.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.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No non conformance reports were generated during production.Drawing was reviewed during this evaluation.No product design issues or discrepancies were observed.Device 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: 5876361
• MDR Text Key: 52107942
• Report Number: 9680938-2016-10125
• 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: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• 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: 08/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• 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
• Patient Outcome(s): Required Intervention