MAUDE Adverse Event Report: SYNTHES SELZACH 8.5MM MEDULLARY REAMER HEAD

Catalog Number 352.085

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

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes eu reports an event in (b)(6) as follows: during surgery, while the surgeon was reaming the intramedullary canal, the reamer head broke.There was a reported fifteen minute surgical delay to surgery.This is report 1 of 1 for com-(b)(4).

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

Additional information - the broken fragments were left in the patient.There was no re-operation needed.

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.

Manufacturer Narrative

Additional narrative: subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: december 4, 2012 no non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Corrected data: the awareness date was inadvertently changed to (b)(6) 2016 on the second supplemental report.The event date was (b)(6) 2016, but the awareness date was (b)(4) 2016.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.

Manufacturer Narrative

Additional narrative: product investigation summary: the received reamer head is broken apart at the end of the coupling hexagon as complained.Furthermore, there are stress marks behind the cutting edges, which are also worn.Not all fragments from the broken part were returned for evaluation.Due to the damage of the device, the relevant dimensions could not be verified.However, no non-conformance records were generated during production, as confirmed during the device history record review.There were no issues during the manufacture of the product that would contribute to this complaint condition.Based on the provided information, the manufacturer is unable to determine an exact root cause; however, it is likely that a mechanical overload situation led to the damage of the received device.No product fault could be detected.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: 8.5MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5467282
• MDR Text Key: 39258702
• Report Number: 2520274-2016-11377
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.085
• Device Lot Number: 27180
• Other Device ID Number: (01)07611819243699(10)27180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2012
• 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
• Patient Age: 30 YR
• Patient Weight: 83